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

Model Number	SIGSBCHGR
Medical Device Problem Codes	Failure to Charge (1085); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that a piece of foreign material was lodged inside the connector.The resistance was measured and confirmed that the material was electrically conductive.Upon attempting to plug the charger into the power supply, sparks were observed from the electrical connector of the charger.With the foreign material removed, the charger was successfully powered on with no sparks or other abnormalities.Functional testing was successfully performed, indicated by verification of a representative power handle and output voltage of 8.4v.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The cause of the reported condition is due to conductive debris causing a short circuit that prevented the charger from successfully powering on.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, pre-operatively, the device charger does not run/work.A new charger was used to resolve the issue.There was no patient involvement.

• 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: 9995276
• Report Number: 1219930-2020-01848
• Device Sequence Number: 14573544
• Product Code: GDW
• UDI-Device Identifier: 10884521543867
• UDI-Public: 10884521543867
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2020

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: 02/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1