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

Model Number OT 8602065

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 283607861
• Report Number: 0008010153-2021-00008
• Device Sequence Number: 1
• Product Code: GDC
• UDI-Device Identifier: 07613327170160
• UDI-Public: 07613327170160
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1