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

Catalog Number	0375542000
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
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 there was foreign material in the sterile packaging.
Additional Manufacturer Narrative
Alleged failure: a red stripe was discovered at the distal end of the shaver blade the failure alleged in the complaint record was not confirmed during the product investigation.Based on the alleged claim the probable root cause/s could be a small amount of plastic (flash) was created during the inductive process or an insertion of the inner cutter accidentally scraped the housing hub and remained attached to the cutter teeth.The improper cleaning process, qc incoming, and in-process inspections.An nc was opened to address the issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was foreign material in the sterile packaging.

• Brand Name: PKG., RESECTOR 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: 11032395
• Report Number: 0002936485-2020-00542
• Device Sequence Number: 1307902
• Product Code: GFA
• UDI-Device Identifier: 37613327061810
• UDI-Public: 37613327061810
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 0375542000
• Device Lot Number: 20210CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2020
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1