MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., BURSECTOR - 4.0MM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	0475541000
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device broke and burned the patient.
Event or Problem Description
It was reported that the device broke and burned the patient.
Additional Manufacturer Narrative
Alleged failure: shaver heated up and broke in half.Burnt the patients arm the failure identified in the investigation is consistent with the complaint record.The probable root cause could be excessive force applied by the user such as bending or prying to the entire assembly with poor or no suction and continued use may cause the inner shaft to fatigue and ultimately break.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG., BURSECTOR - 4.0MM
• 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: 11197364
• Report Number: 0002936485-2021-00040
• Device Sequence Number: 2915679
• Product Code: GFF
• UDI-Device Identifier: 37613327502740
• UDI-Public: 37613327502740
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0475541000
• Device Lot Number: 20191CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other