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 Device Contaminated During Manufacture or Shipping (2969)

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 foreign material was found inside sterile packaging.

Event Description

Please note that this report is now canceled.It is a duplicate report of (b)(4).(stryker (b)(4).

Manufacturer Narrative

Please note that this report is now canceled.It is a duplicate report of (b)(4).(stryker (b)(4).

• 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: 9107133
• MDR Text Key: 164850054
• Report Number: 0002936485-2019-00419
• 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: 10/29/2019

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: 0375544000
• Device Lot Number: NR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1