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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., .012 WIRE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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STRYKER ENDOSCOPY-SAN JOSE PKG, 90 DEG CUTTING LOOP ELECTRODE 24FR., .012 WIRE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Catalog Number 0504880312
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 07/27/2017
Event Type  Injury  
Manufacturer Narrative

Additional information will be provided once the investigation has been completed. The device manufacturer date is not known at this time. However, should it become available it will be provided in future reports. (b)(4).

 
Event Description

It was reported that the tip broke off.

 
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: wire broke. Probable root cause: user excessive force or torque, 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. Manufacture date is not known. (b)(4).

 
Event Description

It was reported that the tip broke off.

 
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Brand NamePKG, 90 DEG CUTTING LOOP ELECTRODE 24FR., .012 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
roomi banerjee dua
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key6876841
MDR Text Key86692963
Report Number0002936485-2017-00881
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number0504880312
Device LOT NumberSTENBB01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2017
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: 09/19/2017 Patient Sequence Number: 1
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