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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE NANOPASS REACH CRESCENT PASSER

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STRYKER ENDOSCOPY-SAN JOSE NANOPASS REACH CRESCENT PASSER Back to Search Results
Model Number CAT02298
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2020
Event Type  malfunction  
Manufacturer Narrative
Alleged failure: dr. (b)(6) bent the first one slightly. And was unable to trigger it afterwards. He did not offer the second one, but still it could not be triggered. The third one worked. Procedure could be completed successfully. The failure(s) identified in the investigation is consistent with the complaint record. The probable root causes could be: excessive force applied on device, user technique related factors, or difficult anatomy, extremely tough soft tissue. The product was returned for investigation and the failure mode will be monitored for future reoccurrence. No manufacturing date - the device manufacturer date is not known.
 
Event Description
Per investigation results, the device was broken at the internal shaft. Per additional information received, the device bent inside the joint and when removed was attempted to be straightened and it broke. No pieces broke inside of the joint.
 
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Brand NameNANOPASS REACH CRESCENT
Type of DevicePASSER
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
andrea zenere
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key10153914
MDR Text Key196006382
Report Number0002936485-2020-00235
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 06/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCAT02298
Device Catalogue NumberCAT02298
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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