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

Model Number	OT 8602065
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by the customer that on (b)(6) 2023 an operon surgical table with serial number (b)(4) had excessive movement.The customer states: ¿the patient was on the table and the doctor noticed that there was excessive movement in the tabletop.The movement was in relation to trend and reverse trend movement.The patient was open there was organ exposure.¿ it was further reported: the procedure being performed was a craniotomy.The procedure continued without delay and without further incident.The patient was not harmed in any way and there was no delay in surgery.A stryker field service technician was dispatched to investigate the alleged incident and confirmed the table serial number.The fst reported: "arrived on site pt on table slip (slid) all the way to the head with an attachment on the table to support head.The issue was that the table was bouncing ( it was balanced over the pivot point of the tabletop allowing the head and foot to go up and down approximately 1/4 inch depending on if pressure was being placed on the pt (patient's) head or foot).Once the case was finished i was able to inspect the table when looking at the trend cylinder the capture nut that holds the i bolt into the trend cylinder shaft was finger tight and when it was a little lose the bolt was able to move back and forth due to the play in the course threads.After this nut was tight there still felt to be some play in the trend cylinder.Opened the table base and also noticed hydraulic fluid under the main lifting cylinder." a copy of the dhr was reviewed and the table passed all quality inspections prior to shipping.The surgical table will be returned to flower mound as a depot repair where it will undergo a complete analysis and all functionalities will be tested, repairs will be made accordingly.A loaner table will be sent to the customer until their table is repaired and returned to the account.The failure mode has not been determined yet however the most probable root cause for this failure mode would be improper maintenance.There was reported patient involvement but there was no report of patient injury, delay in surgery, or adverse consequences.
Event or Problem Description
It was reported that during a procedure there was unintended movement of the table.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: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 16433394
• Report Number: 0008010153-2023-00009
• Device Sequence Number: 14240695
• Product Code: GDC
• UDI-Device Identifier: 07613327170160
• UDI-Public: 07613327170160
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/23/2023

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 Model Number: OT 8602065
• Device Catalogue Number: OT 8602065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/23/2023
• 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