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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE SHEATH, 2.9MM OPERATIVE INNER CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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STRYKER ENDOSCOPY-SAN JOSE SHEATH, 2.9MM OPERATIVE INNER CYSTOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Catalog Number 0502729061
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/28/2016
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 while using a biopsy punch, bioburden, rust and shiny material came out of the cannula.

 
Manufacturer Narrative

Alleged failure: rust and metal debris. Probable root cause: material/design error. Manufacturing/assembly error. Inadequate package seal strength (packaging design). Improper cleaning/sterilization for reusable devices". The product was not returned for investigation therefore the reported failure mode was not confirmed. The failure mode will be monitored for future reoccurrence. Manufacture date is unknown. (b)(4).

 
Event Description

It was reported that while using a biopsy punch, bioburden, rust and shiny material came out odf the cannula.

 
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Brand NameSHEATH, 2.9MM OPERATIVE INNER
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 Key5674790
MDR Text Key45808209
Report Number0002936485-2016-00492
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 COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0502729061
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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