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 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.Mfg date: the date of manufacture is not known.(b)(4).

Event Description

It was reported that the insulation had been compromised.

Manufacturer Narrative

Alleged failure: insulation failure.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be third party repair.The date of manufacture is not known.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.Gtin: (b)(4).

Event Description

It was reported that the insulation had been compromised.

• 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: 7204496
• MDR Text Key: 97946184
• Report Number: 0002936485-2018-00074
• 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: 05/22/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/18/2018
• Supplement Dates Manufacturer Received: 12/21/2017
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1