MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 90 DEG CUTTING LOOP ELECTRODE 24FR., .014 WIRE; CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0504880314

Device Problem Break (1069)

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

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available, it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the tip of the electrode broke off inside the patient.All broken pieces were retrieved successfully.

Manufacturer Narrative

The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: it was reported that the cutting loop fell off tip.It was reported that all pieces were removed from patient.The failure identified in the investigation is consistent with the complaint record.The probable root cause could be user excessive force.Manufacture date is not known.

Event Description

It was reported that the tip of the electrode broke off inside the patient.All broken pieces were retrieved successfully.

• Brand Name: PKG, 90 DEG CUTTING LOOP ELECTRODE 24FR., .014 WIRE
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7997093
• MDR Text Key: 124815980
• Report Number: 0002936485-2018-00665
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 37613327055437
• UDI-Public: 37613327055437
• Combination Product (y/n): N
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0504880314
• Device Lot Number: STENCC01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1