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

Model Number	SIGSBCHGR
Medical Device Problem Codes	Contamination (1120); Corroded (1131); Device Emits Odor (1425)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The charger's event log was evaluated.There were multiple thermistor error messages at the end of the event log, specifically "red err flash: thermistor reading out range".The analog to digital (a2d) counts recorded by the charger on the thermistor line must fall within a specified range.If values are outside the range, thermistor accuracy cannot be confirmed and an error condition is displayed.Evaluation of the clinical power handle returned under this product event identified that the battery cells had vented, and battery electrolyte had been expelled from the battery cells.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.This battery electrolyte most likely contaminated the charging bay; this contamination prevented the charger pogo pins from functioning as intended.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to laparoscopic partial gastrectomy, liquid leakage from the handle was found during inspection before use.Liquid leakage was found from the connection part with the charger, and there was abnormal odor.There was deposition attached on the charger.The handle caused battery error last week, but when it was inserted into the charger, the status was restored, so although there was only one event occurred, the handle has been used continuously.The handle is currently blackout.There was no patient involved.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

• 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: 9961738
• Report Number: 1219930-2020-01746
• Device Sequence Number: 19529272
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 01/22/2020
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1