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

Catalog Number 3105000100

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2019

Event Type  malfunction  

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 Description

It was reported that the product lost traction.

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 Description

It was reported that the product lost traction.

• Brand Name: PIVOT GUARDIAN, FRAME
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8474561
• MDR Text Key: 140774390
• Report Number: 0002936485-2019-00130
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 07613327380361
• UDI-Public: 07613327380361
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3105000100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1