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 05/10/2016

Event Type  Injury  

Manufacturer Narrative

The product was not returned for investigation; therefore, the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence. Alleged failure: loop broken. Probable root cause: user excessive force or torque. Manufacturing/assembly error. Severe shipping conditions. User error in not properly inspecting unit prior to use. Material/design error. Constant irrigation flow is not maintained leading to limited field of view. Low lubricity of insulation for fulgurating electrodes. Incompatible instrumentation used with electrode. Lot number is unknown; therefore, manufacture date can not be confirmed. (b)(4).

Event Description

It was reported that the end loop broke from one side.

• 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: 5701690
• MDR Text Key: 46640220
• Report Number: 0002936485-2016-00533
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): N
• PMA/PMN Number: K040390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: DISTRIBUTOR

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/10/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/06/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 0504880414
• Device LOT Number: TBD
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 06/06/2016 Patient Sequence Number: 1