MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 5MM MULTI-FUNCTION PEEK HANDLE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number 0250181106

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/09/2017

Event Type  malfunction  

Manufacturer Narrative

Alleged failure: burn on insulation at shaft.Confirmed failure: burn on insulation at shaft.Probable root cause: poor autoclave reliability, incorrect sterilization/reprocessing procedure, handling procedures, contact forces, product used beyond defined useful life.The device manufacture date is not known.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported that the insulation had been compromised.

Event Description

It was reported that the insulation had been compromised.

Manufacturer Narrative

Updated awareness date to 11/20/2017 from 12/20/2017.

• Brand Name: PKG, 5MM MULTI-FUNCTION PEEK HANDLE
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7164827
• MDR Text Key: 96468697
• Report Number: 0002936485-2018-00011
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• PMA/PMN Number: K973259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

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: 0250181106
• Device Lot Number: ¿1245039D¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2017
• Initial Date Manufacturer Received: 12/09/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 01/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1