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

Catalog Number 0375545000

Device Problem Contamination (1120)

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

Event Date 05/20/2021

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 inside the sterile packaging.

Event Description

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

Manufacturer Narrative

Alleged failure: between the blade was a strange object when customer opened the package.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be the 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.

• Brand Name: PKG., TOMCAT 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: 12001494
• MDR Text Key: 259474403
• Report Number: 0002936485-2021-00318
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 37613327061797
• UDI-Public: 37613327061797
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375545000
• Device Lot Number: 20356CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1