MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SIGNIA; STAPLE, IMPLANTABLE

Model Number	SIGSBCHGR
Medical Device Problem Codes	Failure to Charge (1085); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The electronic de vice-use logs were also provided.Visual inspection noted there was contamination in the charging bay.Evaluation of the clinical power handle identified that the battery cells had vented, and battery electrolyte had been expelled from the battery cells.This battery electrolyte most likely contaminated the charging bay; this contamination prevented the charger pogo pins from functioning as in tended.The electrolyte is conductive, and would therefore create false readings on the thermistor line, leading to the red error lights identified in the software event log.This would prevent the powered handle from charging.A review of the system logs showed there were multiple thermistor error messages at the end of the event log.It was reported that the battery charger light was red indicating a device issue.The reported issue was confirmed.The most likely cause was not traced to the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, the battery charger was flashing red, and the handle did not work.It was blackout, and there was no operating tone.Another device was used instead.There was no patient involvement.Medtronic's initial evaluation based on the evidence available the reported condition of the handle not working after being removed from the charger was confirmed.The cell venting is an integrated design feature of the cell that produces a discharge of the electrolyte fluid and renders the battery cell nonfunctional and non-chargeable when battery cell life has been exceeded.Root cause of the observed vented battery was determined to be from battery degradation.Device battery management enhancements are being evaluated to extend battery life and enhance battery health monitoring.

• Brand Name: SIGNIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 12099320
• Report Number: 1219930-2021-02625
• Device Sequence Number: 4816290
• Product Code: GDW
• UDI-Device Identifier: 10884521543867
• UDI-Public: 10884521543867
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIGSBCHGR
• Device Catalogue Number: SIGSBCHGR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1