MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG OPERON D850 W SPLIT LEG CONTROL USA; TABLE, OPERATING-ROOM, ELECTRICAL

Catalog Number	OT 1702075
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that during a sinus surgery while the patient was under anesthesia, the legs gave out very quickly and the table went to bottom, head tilted forward with patient on table.The patient was not reported to be injured as the patient was caught/stopped from falling, but due to this a total of 4 staff member were hurt (2 of them noted as injured) and at least 1 x-ray needed to be performed.The procedure was cancelled.
Additional Manufacturer Narrative
It was reported that during a sinus surgery while the patient was under anesthesia, the legs gave out very quickly and the table went to bottom, head tilted forward with patient on table.The patient was not reported to be injured as the patient was caught/stopped from falling, but due to this a total of 4 staff member were hurt (2 of them noted as injured) and at least 1 x-ray needed to be performed.The procedure was cancelled manufacture date is not known.
Event or Problem Description
It was reported that during a sinus surgery while the patient was under anesthesia, the legs gave out very quickly and the table went to bottom, head tilted forward with patient on table.The patient was not reported to be injured as the patient was caught/stopped from falling, but due to this a total of 4 staff member were hurt (2 of them noted as injured) and at least 1 x-ray needed to be performed.The procedure was cancelled.

• Brand Name: OPERON D850 W SPLIT LEG CONTROL USA
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: josh phillips ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 19388174
• Report Number: 0008010153-2024-00011
• Device Sequence Number: 17161731
• Product Code: GDC
• UDI-Device Identifier: 07613327169874
• UDI-Public: 07613327169874
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: OT 1702075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown