MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 24FR 30° CUTTING LOOP ELECTRODE, .014 (6BX) CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Catalog Number 0504880414

Device Problem Break (1069)

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

Event Date 06/07/2016

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. (b)(4).

Event Description

It was reported that the cutting loop broke inside patient during medical procedure. It was confirmed that the broken piece was retrieved from the patient.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed. Alleged failure: tip breakage. The failure(s) identified in the investigation is consistent with the complaint record. The probable root causes could be power set too high, generator power malfunction, or overuse. The failure mode will be monitored for future reoccurrence. Mfg date: 10/19/2015. Gtin: (b)(4).

Event Description

It was reported that the cutting loop broke inside patient during medical procedure. It was confirmed that the broken piece was retrieved from the patient.

• Brand Name: 24FR 30° CUTTING LOOP ELECTRODE, .014 (6BX)
• Type of Device: CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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: 5762224
• MDR Text Key: 48853189
• Report Number: 0002936485-2016-00597
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL,OTHER
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 02/06/2017

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 06/30/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 0504880414
• Device LOT Number: STRJN02
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial