MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG OPERON D 830 SEAT CFK STAINLESS; TABLE, OPERATING-ROOM, ELECTRICAL

Catalog Number	OT 8302065
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that when putting the table in reverse trend and the table came off the ground.They had to hit table up and it came crashing down.They were doing a lap chole and patient was supine in normal orientation.There were incisions made, but no harm was done.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
It was reported by tanner med ctr villa rica-unconfirmed or (table s/n (b)(6) it was emailed in stating putting the table in reverse trend and the table came off the ground.They had to hit table up and it came crashing down.They were doing a lap chole and patient was supine in normal orientation.Patient was only 128 lbs.There were incisions made, but no harm was done.A stryker field service technician was sent out on 25 aug 2025, it was discovered "inspected table for physical damage - none found.Table working normally.No issues with the table.Talked to staff - the table was in head down position, when they lowered the table - they found the leg extension was on top of the mayo stand.This made the base of the table rise.", there were no issues found with the table functionality.In the operon operator's manual it is listed, "the expected life of the operon® or tables is 10 years from the date of product installation.", this product was manufactured in 2014 and complaint was reported in 2025 meaning it is an 11 year old table.There is also a clear warning in this manual listing "objects lying on the base cover can end up against the telescoping column shields when the or table is being repositioned and cause damage to the covers and brackets inside the covers.1.Never place objects on the base cover." the root cause of the issue was found to be the objects placed near the base of the table leading to unintended movement, which can be traced to user error.This issue was discovered during a procedure, 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 when putting the table in reverse trend and the table came off the ground.They had to hit table up and it came crashing down.They were doing a lap chole and patient was supine in normal orientation.There were incisions made, but no harm was done.There were no reported injuries or adverse consequences.

• Brand Name: OPERON D 830 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: andy dobos ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 23080083
• Report Number: 0008010153-2025-00007
• Device Sequence Number: 21262411
• Product Code: GDC
• UDI-Device Identifier: 07613327170061
• UDI-Public: 07613327170061
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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 8302065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2014
• 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
• Patient Weight: 58 KG