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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE BIOPSY PUNCH 5FR SEMI FLE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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STRYKER ENDOSCOPY-SAN JOSE BIOPSY PUNCH 5FR SEMI FLE CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Catalog Number 0502555200
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 07/08/2016
Event Type  Injury  
Manufacturer Narrative

Additional information will be provided once the investigation has been completed. (b)(4).

 
Event Description

It was reported that the grasper broke inside the patient. The procedure was completed successfully.

 
Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence. Alleged failure: not working correctly during procedure and broke inside the patient probable root cause: user excessive force or torque. Manufacturing/assembly error. User error in not properly inspecting unit prior to use. Material/design error. Constant irrigation flow is not maintained leading to limited field of view. Low lubricity of instrument shaft. Use of incompatible instrumentation/hardware. Corrosion or rusting. Improper cleaning/sterilization. (b)(4).

 
Event Description

It was reported that the grasper broke inside the patient. The procedure was completed successfully.

 
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Brand NameBIOPSY PUNCH 5FR SEMI FLE
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
kimberly lynch
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key5842166
MDR Text Key50999035
Report Number0002936485-2016-00713
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/02/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0502555200
Device LOT Number1540187
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/26/2015
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: 08/02/2016 Patient Sequence Number: 1
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