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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 Problems Cord (768); Temperature Problem (3022)
Patient Problem Burn(s) (1757)
Event Date 09/05/2018
Event Type  Injury  
Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed. The reported failure mode will be monitored for future reoccurrence. Alleged failure: bovie cord broke and patient burned. Probable root cause: insulation melting, excessive cauterization, manufacturing/assembly error, break or crack in cable insulation, use error. The device manufacture date is not known.

 
Event Description

It was reported that the patient was burned by the cord during a procedure.

 
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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
chester rebugio
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key7924482
MDR Text Key122298911
Report Number0002936485-2018-00627
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
Report Date 10/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0502990300
Device LOT Number844270
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/01/2018 Patient Sequence Number: 1
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