MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PACKAGING, FORMULA SHAVER (HAND CONTROL); BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	0375704500
Medical Device Problem Code	Electrostatic Discharge (2149)
Health Effect - Clinical Codes	Shock (2072); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the surgeon was shocked by the product.The procedure was completed successfully.
Additional Manufacturer Narrative
Alleged failure: surgeon complains that they were being shocked.Probable root cause: isolation circuit failure.Moisture gets into housing.Damaged motor.Damaged/frayed cable.Use error: the product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the surgeon was shocked by the product.The procedure was completed successfully.

• Brand Name: PACKAGING, FORMULA SHAVER (HAND CONTROL)
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8932399
• Report Number: 0002936485-2019-00358
• Device Sequence Number: 430481
• Product Code: GFF
• UDI-Device Identifier: 07613327057638
• UDI-Public: 07613327057638
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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 Catalogue Number: 0375704500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1