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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure there was unintended movement of the table after being lowered on an external piece of equipment.There were no reported injuries.
Additional Manufacturer Narrative
It was reported "the d860 table (s/n: (b)(4)) was in use during a case and was lowered on top of the patient warmer that was under the table, lifting it up off the floor at the head end.That was realized and immediately remedied.Later on during the same case, the bed suddenly jerked and fell downward.It then jerked down again, and then again.The bed fell 3 times until it was in its lowest position.The patient was strapped to the bed and was not injured; however, it was after incision." (b)(4) was opened on (b)(6) 2021.A stryker field service technician was dispatched and responded to the complaint on 3 nov 2021 and provided the following report: "after accessing the table i did a visual inspection and did not find any damage to the outside of the table.I tested all functions with the hand pendant and cycle tested the table with the software with no errors or issues.I then opened up the base to check for any damage and once again everything looked good." the root cause for this failure mode, and confirmed by the customer, is customer misuse.The customer reported that the table was lowered onto a device that was being stored on or near the base of the table, which is not allowed.The table collided with the device which caused the table center lift column to jam.After the device was dislodged from the table base by the customer the surgical procedure resumed without properly checking all functions of the table prior to use.Later, during surgery the table unjammed and lowered to its hydraulic limit.The patient was secured at all times and there was no report of patient or user injury.

• 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: 12909411
• Report Number: 0008010153-2021-00008
• Device Sequence Number: 4751345
• Product Code: GDC
• UDI-Device Identifier: 07613327170160
• UDI-Public: 07613327170160
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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
• 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: 11/02/2021
• Initial Report FDA Received Date: 12/01/2021
• 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