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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
Catalog Number CAT02298
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/28/2018
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.
 
Event Description
It was reported that the tip broke during the procedure. All pieces were retrieved successfully.
 
Event Description
It was reported that the tip broke during the procedure. All pieces were retrieved successfully.
 
Manufacturer Narrative
Alleged failure: tip break. Probable root cause: design inadequate raw material selection, tip geometry not designed to facilitate soft tissue penetration manufacturing, instrument tip or needle shaft not manufactured to specification, incorrect raw materials used for manufacture application, user technique related factors, difficult anatomy, extremely tough soft tissue. 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.
 
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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
MDR Report Key7996047
MDR Text Key124809220
Report Number0002936485-2018-00660
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCAT02298
Device Lot Number003286
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

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