MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., ANGLED AGG. PLUS SHAVER BLADE F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0380544100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2019
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 product broke during the procedure.All pieces were removed and the procedure was completed successfully.
Event or Problem Description
It was reported that the product broke during the procedure.All pieces were removed and the procedure was completed successfully.
Additional Manufacturer Narrative
The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: sheer blade internal component came apart into many pieces in the patient.Dr chan was able to remove all the pieces but this did cause a delay and concern for surgeon.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be bending/prying or came in contact with a hard object.

• Brand Name: PKG., ANGLED AGG. PLUS SHAVER BLADE F - SERIES - 4.0MM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8286379
• Report Number: 0002936485-2019-00034
• Device Sequence Number: 11438461
• Product Code: GFA
• UDI-Device Identifier: 37613327054997
• UDI-Public: 37613327054997
• 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): 05/20/2019

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: 0380544100
• Device Lot Number: 18195CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 71