MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 5MM MONOPOLAR HANDLE 33CM; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number 0250080233

Device Problem Detachment Of Device Component (1104)

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

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

The button screw cover cap located on the proximal end of the device is missing.Also it was noted cracks, dents and scratches where seen on insulation.Functional inspection : the instrument failed the insul scan.The probable root causes are normal wear, user misuse and improper sterilization methods.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 that a cap on the screw below the push putton came off.

• Brand Name: 5MM MONOPOLAR HANDLE 33CM
• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5109505
• MDR Text Key: 27063708
• Report Number: 0002936485-2015-00859
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K973259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250080233
• Device Lot Number: 1340503D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Date Manufacturer Received: 09/02/2015
• 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