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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 24FR 90° CUTTING LOOP ELECTRODE, .012 (6BX) CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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STRYKER ENDOSCOPY-SAN JOSE 24FR 90° CUTTING LOOP ELECTRODE, .012 (6BX) CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Catalog Number 0504880312
Device Problems Break (1069); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/27/2016
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 electroloop at the distal tip broke off in patient. Tip was retrieved.

 
Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed. Alleged failure: electroloop at the distal tip broke off in patient it was retrieved. The probable root causes could be power set too high, generator power malfunction, or overuse. The reported failure mode will be monitored for future reoccurrence. (b)(4). Mfg date: manufacture date is not known.

 
Event Description

It was reported electroloop at the distal tip broke off in patient. Tip was retrieved.

 
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Brand Name24FR 90° CUTTING LOOP ELECTRODE, .012 (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 Key6045827
MDR Text Key58028827
Report Number0002936485-2016-00992
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 COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/21/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0504880312
Device LOT NumberSTRGN01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/30/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2016
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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