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 Unspecified Tissue Injury (4559)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer that on (b)(6) 2021 during a gall bladder procedure (lap coli), the operon d860 with udi# ((b)(4)) experienced unintended movement.The customer reported the movement was the result of the table getting caught on an external piece of equipment and not an issue with the table itself.The customer reported they were moving the patient into 'reverse trendelenburg' and the end of the table got caught on a "mayo" stand.The customer then tried to pull the equipment that was stuck out from under the table.The entire table subsequently shifted down while in 'reverse trendelenburg' causing the table leg section to collide with the stainless steel base covers.At the time of the unintended movement, there were instruments inside of the patient which caused punctures and lesions requiring immediate treatment.The customer was unable to perform the original gall bladder procedure (lap coli) and the patient was closed and removed from the table.A review of the device history record (dhr) was completed.There were no failures noted during the manufacturing or final quality inspection process.On (b)(6) 2021, a stryker field service technician (sfst) was able to conduct an on-site evaluation of the operon d860 with udi# ((b)(4)) and took photos of the damage to the table.The sfst removed all table sections and verified that they removed easily and attached securely.The sfst checked the error log and found none, ran a full cycle test and no errors appeared, ran the table through all functions with the hand pendant and received no error codes.The sfst reported the operon d860 with udi# ((b)(4)) was functioning as intended and that there was damage present on the table base cover and on the bottom of the leg spars.Although we could not confirm the root cause at this time the most likely root cause is user error.The user placed an external piece of equipment under the leg section and as the table was articulated into the reverse trendelenburg position the leg section collided with the external piece of equipment.Dislodging the external piece of equipment from under the leg section caused the table to drop suddenly.We are currently waiting on additional information from the customer regarding the extent of the patient¿s injuries.Once additional information is obtained around this event a supplemental report¿rt will be filed.Per ifu 57445 rev m, section 4.1 states: ¿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.Never place objects on the base cover.¿ also, per ifu 57445 rev m, section 6.12 states: ¿the or table cannot detect objects placed on the base cover.Placing objects/accessories on the or table base can cause damage to the table and/or accessories if the table surface is lowered or a collision occurs.¿.

Event Description

It was reported when the table was moved into position the table experienced unintended movement after being caught on an external piece of equipment during a procedure.The unintended movement resulted in patient injury.

Event Description

It was reported when the table was moved into position the table experienced unintended movement after being caught on an external piece of equipment during a procedure.The unintended movement resulted in patient injury.

Manufacturer Narrative

[supplemental 001] field f10/h6 component code grid was updated.

• 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
• MDR Report Key: 11713583
• MDR Text Key: 262882365
• Report Number: 0008010153-2021-00002
• Device Sequence Number: 1
• Product Code: GDC
• UDI-Device Identifier: 07613327170160
• UDI-Public: 07613327170160
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: OT 8602065
• Device Catalogue Number: OT 8602065
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other