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

Catalog Number	3105000100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2019
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 the product lost traction.
Additional Manufacturer Narrative
The failure mode was confirmed.The product was received by the legal manufacturer, composite manufacturing.The oem investigation report is attached (see communication log), and indicates: root cause analysis alleged failure confirmed?: yes.Probable root cause: damage during use.Investigation conclusion tenzor was taken apart and components replaced, parts were very loose from some sort of user damage.This functionality is tested 100% before going out the door.The failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
Event or Problem Description
It was reported that the product lost traction.

• 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: 8474561
• Report Number: 0002936485-2019-00130
• Device Sequence Number: 16409626
• Product Code: HST
• UDI-Device Identifier: 07613327380361
• UDI-Public: 07613327380361
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 10/11/2019

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 Catalogue Number: 3105000100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1