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U.S. Department of Health and Human Services

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

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STRYKER ENDOSCOPY-SAN JOSE 24FR 30° CUTTING LOOP ELECTRODE, .014 (6BX) CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
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.

 
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Brand Name24FR 30° CUTTING LOOP ELECTRODE, .014 (6BX)
Type of DeviceCYSTOSCOPE 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 Key5701690
MDR Text Key46640220
Report Number0002936485-2016-00533
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
PMA/PMN NumberK040390
Number of Events Reported1
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 Received06/06/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0504880414
Device LOT NumberTBD
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2016
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
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