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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, ROTATING HANDLE, INSULATED SHAFT; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
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STRYKER ENDOSCOPY-SAN JOSE PKG, ROTATING HANDLE, INSULATED SHAFT; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED Back to Search Results
Catalog Number 0250080233
Device Problem Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2018
Event Type  malfunction  
Manufacturer Narrative
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.(b)(4).
 
Event Description
It was reported that the insulation had been compromised.
 
Manufacturer Narrative
The device manufacture date is not known.Alleged failure: failed insulation.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be user misuse, excessive force, normal wear, or improper sterilization methods.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.
 
Event Description
It was reported that the insulation had been compromised.
 
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Brand Name
PKG, ROTATING HANDLE, INSULATED SHAFT
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 Key7501368
MDR Text Key107983868
Report Number0002936485-2018-00418
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 08/10/2018
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 Number0250080233
Device Lot Number0541390D
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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