MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CONNECTED OR MOUNT; CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)

Catalog Number 0240099158

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2022

Event Type  malfunction  

Event Description

It was reported that the arm of cart was drifting.

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.

Manufacturer Narrative

The product was returned to the supplier for investigation and the reported failure mode was confirmed.Alleged failure: tilt bracket not working.Tekna investigation results: "on(b)(6) 2022, (b)(6) mounted an sv7 monitor to a monitor stow handle and this tilter.It was a little loose and tilted down completely very easily.He tightened up the set screw and then was able to position the monitor in any position and it maintained its position.We cycled the tilter up and down many times and it is still working properly.Moving it up is harder to do and is a little ¿jerky¿.It does move much easier going down, but when it is positioned, it stays.It is a significant amount of force to tighten the set screw, but that does seem to address the issue.On the morning of (b)(6) 2022, it was still holding its position.No problem can be found, so no further action will be taken." the reported failure mode will be monitored for future re occurrence.Manufacture date is not known.

Event Description

It was reported that the arm of cart was drifting.

• Brand Name: CONNECTED OR MOUNT
• Type of Device: CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14076993
• MDR Text Key: 294541432
• Report Number: 0002936485-2022-00174
• Device Sequence Number: 1
• Product Code: BZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 0240099158
• Device Lot Number: UKN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1