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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 Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2018
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 insulation had been compromised.
 
Manufacturer Narrative
Alleged failure: eib pcs jen, failed insulation po 043b.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could (1) improper cleaning or sterilization (2) normal wear.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
 
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
MDR Report Key7501364
MDR Text Key107968725
Report Number0002936485-2018-00414
Device Sequence Number1
Product Code OCZ
Combination Product (y/n)N
PMA/PMN Number
K973259
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0250080617
Device Lot Number1040660D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2018
Date Manufacturer Received04/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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