MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., AGG. PLUS SHAVER BLADE, SMALL JOINT, F - SERIES - 2.5MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 0375628000

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/22/2021

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 foreign object was spotted inside the packaging of the sterile shaverblade.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be an improper cleaning process, qc incoming, and in-process inspection.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., AGG. PLUS SHAVER BLADE, SMALL JOINT, F - SERIES - 2.5MM
• 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: 12344452
• MDR Text Key: 268688965
• Report Number: 0002936485-2021-00443
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 37613327061988
• UDI-Public: 37613327061988
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375628000
• Device Lot Number: 19336CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Date Manufacturer Received: 07/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1