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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 Problems Break (1069); Detachment Of Device Component (1104); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). 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 complete round tip broke from both sides inside the patient and detached from the electrode. The tip was retrieved. There was no medical intervention and a replacement device was readily available to complete the procedure successfully.

 
Manufacturer Narrative

(b)(4). Device lot number was not provided; therefore manufacture date is not known. Alleged failure: tip 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. The product was not returned for investigation therefore the reported failure mode was not confirmed. The reported failure mode will be monitored for future reoccurrence.

 
Event Description

It was reported that the complete round tip broke from both sides inside the patient and detached from the electrode. The tip was retrieved. There was no medical intervention and a replacement device was readily available to complete the procedure successfully.

 
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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 Key5698305
MDR Text Key47613628
Report Number0002936485-2016-00526
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,Followup
Report Date 05/10/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/03/2016
Is This An Adverse Event Report? No
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? No
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

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