PIVOT GUARDIAN, FRAME
Received Jan 7, 2021 · Event occurred Dec 11, 2020
Report 0002936485-2021-00006 · MDR key 11132323
Device
Generic name
Apparatus, Traction, Non-powered
Manufacturer
Stryker Endoscopy-san JoseModel number
3105000100Catalog number
3105000100
Product problems
- Mechanical Problem
- Therapeutic or Diagnostic Output Failure
Patient
Not reported
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A LOSS OF TRACTION DURING THE PROCEDURE.
Additional Manufacturer Narrative
THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: LOCKING MECHANISM SKIPPED OUT AND LOOSENED TRACTION. PROBABLE ROOT CAUSE: DESIGN: MATERIALS BEND/DENT UNDER FORCE. DESIGN OF JOINTS AND LOCKING MECHANISMS. CONNECTORS OR LOCKS BREAK UNDER TRACTION FORCE. CASTERS SLIP ON FLOOR. BOOT SPINE BENDS. BOOT BOAS UNREEL DUE TO TORQUE LIMIT. BOA CONNECTION GUIDE BREAKS UNDER HIGH TENSION. PATIENT POSITION PAD SLIDES ON TABLE OR PATIENT SLIDES ON TOP OF PAD. PATIENT POSITION BELT NOT STRONG ENOUGH TO PREVENT PATIENT FROM ROLLING USE ERROR. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE DATE OF MANUFACTURE IS NOT KNOWN. H3 OTHER TEXT : 81.
Additional 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.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A LOSS OF TRACTION DURING THE PROCEDURE.