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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 10MM PEEK MONOPOLAR HANDLE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

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STRYKER ENDOSCOPY-SAN JOSE PKG, 10MM PEEK MONOPOLAR HANDLE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED Back to Search Results
Catalog Number 0250080618
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2018
Event Type  malfunction  
Manufacturer Narrative
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
Gtin: (b)(4).Alleged failure: insulation compromised.Probable root cause: poor autoclave reliability, incorrect sterilization/reprocessing procedure, handling procedures, contact forces, product used beyond defined useful life.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.
 
Event Description
It was reported that the insulation had been compromised.
 
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Brand Name
PKG, 10MM 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
ashley lower
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key7340046
MDR Text Key102458262
Report Number0002936485-2018-00249
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 company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0250080618
Device Lot Number1446463H¿
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/15/2018
Initial Date FDA Received03/14/2018
Supplement Dates Manufacturer Received02/15/2018
Supplement Dates FDA Received06/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2014
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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