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

Device Problem Packaging Problem (3007)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was foreign material in the sterile packaging.

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 Description

It was reported that there was foreign material in the sterile packaging.

• Brand Name: PKG., RESECTOR SHAVER BLADE, F - SERIES - 4.0MM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11032395
• MDR Text Key: 222648547
• Report Number: 0002936485-2020-00542
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 37613327061810
• UDI-Public: 37613327061810
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1