MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, ROTATING HANDLE, INSULATED SHAFT; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number 0250080233

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device manufacture date is not known.Alleged failure: coating peeling off handle.Confirmed failure: coating peeling off handle,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 product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported the insulation is compromised.

• Brand Name: PKG, ROTATING HANDLE, INSULATED SHAFT
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: roomi banerjee dua ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7183857
• MDR Text Key: 97091245
• Report Number: 0002936485-2018-00052
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2018

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: 0250080233
• Device Lot Number: ¿1246182D¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1