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

Catalog Number 0375544000

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2019

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 there was foreign material in the sterile packaging.

Manufacturer Narrative

Manufacture date is not known.Alleged failure: a blue foreign material was found inside the package.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be improper cleaning process, qc incoming, and in-process inspections, environmental conditions.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, 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: 9106454
• MDR Text Key: 165305761
• Report Number: 0002936485-2019-00415
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 37613327061780
• UDI-Public: 37613327061780
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0375544000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1