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

Catalog Number 0250080234

Device Problems Device Or Device Fragments Location Unknown (2590); Misassembly by Users (3133)

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

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there were missing parts on the handle and third party insulation issues.

Manufacturer Narrative

The following repair diagnostic codes were identified: (broken/fractured handle).This does confirm the alleged failure mode of [missing piece on handle].Probable root cause: poor autoclave reliability, incorrect sterilization/reprocessing procedure, handling procedures, use error, shear pin failure in handle.(proximal end of device).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 there were missing parts on the handle and third party insulation issues.

• Brand Name: 5MM RATCHETED 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: 5257418
• MDR Text Key: 32490653
• Report Number: 0002936485-2015-01084
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0250080234
• Device Lot Number: 11062015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• 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