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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 90 DEG CUTTING LOOP ELECTRODE 24FR., .014 WIRE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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STRYKER ENDOSCOPY-SAN JOSE PKG, 90 DEG CUTTING LOOP ELECTRODE 24FR., .014 WIRE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Catalog Number 0504880314
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2018
Event Type  Malfunction  
Manufacturer Narrative

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 tip of the electrode broke off inside the patient. All broken pieces were retrieved successfully.

 
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Brand NamePKG, 90 DEG CUTTING LOOP ELECTRODE 24FR., .014 WIRE
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
andrea zenere
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key7997091
MDR Text Key124810895
Report Number0002936485-2018-00664
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK040390
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/14/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0504880314
Device LOT NumberSTENCC01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/15/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2018
Was Device Evaluated By Manufacturer? Yes
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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