The Food & Drug Administration sent a warning letter to Starion Instruments Corp. after determining that the company failed to correctly report a series of malfunctions of its thermal ligating shears.
According to the August 10 letter, inspections of the Sunnyvale, Calif.-based company’s plant in February revealed problems with Starion’s malfunction reporting system and with its procedures for handling complaints. FDA rules require medical device makers to inform the watchdog agency within 30 days of receiving reports of malfunctions that could "contribute to a death or serious injury." Citing three complaints the company received, the FDA said Starion failed to report incidents in which nine of the instruments’ jaws broke during procedures and four more components of another device fragmented during a single procedure.
The agency said it wasn’t satisfied with a March reply Starion president and COO Sharad Joshi sent regarding the problems unearthed during the inspections.
"We have reviewed your response and have concluded that it is inadequate because the devices were falling apart or breaking during normal use and this poses a risk to health," according to the warning letter.
The malfunctions occurred with Starion’s TLS3 thermal ligating shears and TLS4 RealHand thermal seal device, according to the letter. The devices, which are used to cut and cauterize tissue during surgical procedures, were the subjects of a trio of Class II recalls in July and August. Class II recalls are for devices that have a lower chance of causing major injuries or death than devices in Class I recalls, but still present the possibility of adverse events with irreversible consequences.
The FDA also flagged Starion for failing to submit notice of the complaints by April 30 and for failing to submit documentation of its adverse event reporting and complaint handling procedures and said it would have to re-inspect the plant "to assure that corrections are adequate."
Starion has 15 days from the date it received the warning letter to respond to the agency, detailing the steps it’s taken to address the problems.