MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG OPERON D 860 SEAT PHENOLIC STAINLESS; TABLE, OPERATING-ROOM, ELECTRICAL

Catalog Number	OT 8601065
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
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 the table raised up 6 inches off the floor during a procedure.Based on images received, the table collided with another device.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
It was reported "(b)(6) unconfirmed or (table s/n (b)(6)-table raised up 6 inches off the floor during a procedure.Need tech to investigate." two images were received of the issue faced by the customer.In the first image it is clear that something left a dent within the base cover of the table.In the second image it shows how the table was lifted off of the ground.The onsite investigation case was cancelled due to the account deeming the table to be fit for use.Due to this cancellation a technician was not able to go on site for additional investigation.Based on images provided by the customer, it can be determined that something was place on the base of the table which could have led to the unintended movement.Listed within the operator manual surgical mobile operating table models d 860, d 850, d 830, d 820, d770, d 760 (57445, rev ya) is a description of keeping objects off of the base cover because this can lead to damage to the table.A review of the device history was completed.According to the manufacturing dhr, the table was manufactured on 26 apr 2018 and met quality specifications prior to shipment.This issue was discovered during surgery, and there was no patient impact and no adverse event reported.This failure mode has not exceeded any threshold and will continue to be monitored.
Event or Problem Description
It was reported that the table raised up 6 inches off the floor during a procedure.Based on images received, the table collided with another device.There were no reported injuries or adverse consequences.

• Brand Name: OPERON D 860 SEAT PHENOLIC 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 ; 74611810
• MDR Report Key: 23882935
• Report Number: 0008010153-2025-00010
• Device Sequence Number: 9464833
• Product Code: GDC
• UDI-Device Identifier: 07613327170078
• UDI-Public: 07613327170078
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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 8601065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2018
• 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