MAUDE Adverse Event Report: BERCHTOLD GmbH & Co. KG OPERON D 860 SEAT CFK STAINLESS; table, operating-room, electrical

Catalog Number	OT 8602065
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
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 in a surgery when trying to lower the bed in reverse trend, the d860 table height dropped out from under the patient abruptly to the lowest height.After that happened, they were able to continue to use the table, all functions appeared to work and they were able to complete the procedure.It was later determined that they had a mistral-air machine under the leg section of the table and lowered the table and only the head side lowered until they kicked out the machine and the table dropped.There were no reported injuries or adverse consequences.

• Brand Name: OPERON D 860 SEAT CFK STAINLESS
• 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: arsalan rizvi ; ludwigstaler straße 25; tuttlingen 78532 ; GM 78532 ; +49()74611810
• MDR Report Key: 25612520
• Report Number: 0008010153-2026-00005
• Device Sequence Number: 21325110
• Product Code: GDC
• UDI-Device Identifier: 07613327170160
• UDI-Public: 07613327170160
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: OT 8602065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• 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