MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PIVOT GUARDIAN, FRAME; APPARATUS, TRACTION, NON-POWERED

Model Number	3105000100
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that there was a loss of traction during the procedure.
Event or Problem Description
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.

• Brand Name: PIVOT GUARDIAN, FRAME
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11132323
• Report Number: 0002936485-2021-00006
• Device Sequence Number: 2350190
• Product Code: HST
• UDI-Device Identifier: 07613327380361
• UDI-Public: 07613327380361
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3105000100
• Device Catalogue Number: 3105000100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1