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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, RESECTOSCOPE CABLE, (VALLEYLAB/BOVIE) CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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STRYKER ENDOSCOPY-SAN JOSE PKG, RESECTOSCOPE CABLE, (VALLEYLAB/BOVIE) CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Catalog Number 0502990300
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2016
Event Type  Malfunction  
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 cord split into two pieces and had a burned connection.

 
Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed. Alleged failure: the piece that connect to laparoscopic instrument burned off. Surgeon felt it hotter, the cord split into two separate pieces. Did not hurt patient or cause fire. 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, improper sterilization methods, or improper drying the reported failure mode will be monitored for future reoccurrence. (b)(4).

 
Event Description

It was reported that the cord split into two pieces and had a burned connection.

 
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Brand NamePKG, RESECTOSCOPE CABLE, (VALLEYLAB/BOVIE)
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
victoria milich
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key6153486
MDR Text Key62141203
Report Number0002936485-2016-01144
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 06/07/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/07/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0502990300
Device LOT Number1090782
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/14/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/11/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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