MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., RESECTOR SHAVER BLADE, F - SERIES - 5.5MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number 0375562000

Device Problem Break (1069)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the device broke during the procedure.All pieces were retrieved.

Event Description

It was reported that the device broke during the procedure.All pieces were retrieved.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: broke during use.Probable root cause: inadequate window profile; inadequate welding process; improper material strength; inadequate size selected for the application; material brittleness; excessive force applied by the user; incorrect rfid tag.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

• Brand Name: PKG., RESECTOR SHAVER BLADE, F - SERIES - 5.5MM
• 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: 11060924
• MDR Text Key: 223618511
• Report Number: 0002936485-2020-00557
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 07613327061871
• UDI-Public: 07613327061871
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0375562000
• Device Catalogue Number: 0375562000
• Device Lot Number: 19227CE2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR