MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS SUSPENSION, SINGLE UNIVERSAL FLAT PANEL, 9' CEILING; TABLE, OPERATING-ROOM, AC-POWERED

Catalog Number	0682000850
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the monitor yoke in gi rm 1 has separated from the spring arm, and is only held on by the cables.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the monitor yoke in gi rm 1 has separated from the spring arm, and is only held on by the cables.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
It was reported that the monitor yoke in gi rm 1 had separated from the spring arm, and only held on by the cables.The product was inspected by field service technician (fst) who reported on the field service investigation that damaged spring arm and yoke were removed and replaced with new spring arm and yoke.The fst also confirmed that "this is a billable account with no pm (preventive maintenance) history" and "have not had any service tickets that would indicate abuse on the equipment".Since this is a legacy product, there is no manufacturing dhr or qip available for this record.However, based on a phone conversation with the data analyst on may 8th, 2024, the serial number was tracked down in a legacy system (oracle report), and was able to confirm that the order for this sn was shipped on december 26th, 2007, and installation sign off took place on april 25th, 2008.Although the exact root cause of this issue is unknown, the fst was able to confirm that the m3 screw was missing at the time of his inspection visit, and this missing screw would cause the keeper clip to back out and ultimately ending in the separation of the yoke from the spring arm.Because fst also confirmed that there are no preventative maintenance records on this account available to stryker, the most likely root cause would be attributed to a maintenance issue on this legacy product.As was reported, this issue was resolved by the fst after replacing spring arm and yoke, and there was no patient involvement or adverse event.This failure mode has not exceeded any thresholds and will continue to be monitored.If any further information is received, a supplemental will be filed.

• Brand Name: SUSPENSION, SINGLE UNIVERSAL FLAT PANEL, 9' CEILING
• Common Device Name: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer (Section G): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer Contact: kimberly lynch ; 571 silveron blvd; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 19076338
• Report Number: 0002031963-2024-00003
• Device Sequence Number: 6826208
• Product Code: FQO
• UDI-Device Identifier: 07613327166736
• UDI-Public: 07613327166736
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/04/2024

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: Other
• Device Catalogue Number: 0682000850
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown