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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 06/07/2016
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. (b)(4).

 
Event Description

It was reported that the cutting loop broke inside patient during medical procedure. It was confirmed that the broken piece was retrieved from the patient.

 
Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed. Alleged failure: tip breakage. The failure(s) identified in the investigation is consistent with the complaint record. The probable root causes could be power set too high, generator power malfunction, or overuse. The failure mode will be monitored for future reoccurrence. Mfg date: 10/19/2015. Gtin: (b)(4).

 
Event Description

It was reported that the cutting loop broke inside patient during medical procedure. It was confirmed that the broken piece was retrieved from the patient.

 
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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 Key5762224
MDR Text Key48853189
Report Number0002936485-2016-00597
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,OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0504880414
Device LOT NumberSTRJN02
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/10/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/19/2015
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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