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: Other
• 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
• 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 Sequence Number: 1
• Patient Outcome(s): Other