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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, .014 CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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STRYKER ENDOSCOPY-SAN JOSE 22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, .014 CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Catalog Number 0504990314
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2016
Event Type  Malfunction  
Manufacturer Narrative

Alleged failure: loop breaking. Probable root cause: poor autoclave reliability; incorrect sterilization/reprocessing procedure; handling procedures; use error; shear pin failure in handle. The product was not returned for investigation; therefore, the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence. The device manufacturer date is not known. (b)(4).

 
Event Description

It was reported that the loop broke off inside the patient but the piece was retreived.

 
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Brand Name22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, .014
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 Key5765271
MDR Text Key48860272
Report Number0002936485-2016-00604
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK040390
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 06/06/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/01/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0504990314
Device LOT NumberSTRKN02
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2016
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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