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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 5MM PEEK MONOPOLAR HANDLE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
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STRYKER ENDOSCOPY-SAN JOSE PKG, 5MM PEEK MONOPOLAR HANDLE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED Back to Search Results
Catalog Number 0250080617
Device Problem Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/23/2018
Event Type  malfunction  
Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: burn on insulation at shaft.Confirmed failure: burn on insulation at shaft.Probable root cause: poor autoclave reliability.Incorrect sterilization/reprocessing procedure.Handling procedures.Contact forces.Product used beyond defined useful life.(b)(4).
 
Event Description
It was reported that the insulation had been compromised.
 
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Brand Name
PKG, 5MM PEEK MONOPOLAR HANDLE
Type of Device
ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
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 Key7355214
MDR Text Key103026741
Report Number0002936485-2018-00264
Device Sequence Number1
Product Code OCZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K973259
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0250080617
Device Lot Number¿1448467H¿
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2018
Date Manufacturer Received02/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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