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 Problems Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that foreign material was found in sterile packaging.

Manufacturer Narrative

Alleged failure: reported that there was red paint within the teeth of the burr the failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be it is possible that a small amount of plastic ¿red flash¿ was created during the inductive weld process and was not removed.The inner cutter accidentally scraped the housing hub during insertion and remained attached to the cutter teeth.Improper cleaning process, qc incoming, and in-process inspections.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

Event Description

It was reported that foreign material was found in 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: 8976354
• MDR Text Key: 156964493
• Report Number: 0002936485-2019-00376
• 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,other
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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
• Device Operator: Other
• Device Catalogue Number: 0375542000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2019
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1