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

Catalog Number OT 8601065

Device Problem Use of Device Problem (1670)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 10/13/2023

Event Type  Death  

Manufacturer Narrative

It was reported the operon d860 ¿slide function was not moving in position¿ and customer was requesting a technician to assess the table.Additionally, the customer stated the ¿surgeon claimed the table functionality led to delay in procedure which was the contributing factor to a patient¿s death¿.The technician visited the account to perform his investigation on the reported failure.Stryker¿s investigation into the table's slide function revealed no anomalies or defects.The ¿customer stated that the table was unable to be slid far enough when the case demanded it¿.The technician conducted full-cycle tests on all table functions, checked the table's software for errors, and confirmed that the table was operating as designed and within specifications.According to the customer's feedback, during an open-heart surgery, medical complications necessitate repositioning the patient to add an imaging extension accessory.Installing the accessory involves removing the table's leg section and inserting the imaging extension accessory.However, the customer encountered difficulties in attaching the imaging extension while the patient was on the table, resulting in medical delay.The imaging extension is supplied by an oem supplier.While the exact root cause remains unconfirmed, the information provided suggests that the surgical table had no malfunction and the likely contributing factor was the surgical room layout and the placement of the table, which hindered the attachment of the surgical table's imaging extension.In the event that we receive additional information, a supplemental will be filed.

Event Description

It was reported that during procedure the table's slide function was not moving in position.It was further stated in the surgeon's post operation report that the table was unable to slide correctly causing delays in open heart procedure and patient passed away.The reported delay was 1 hour.Additional information determined that during the open-heart surgery, medical complications occurred which necessitated repositioning the patient to add an imaging extension accessory.The surgeon claimed the table functionality led to this delay in procedure which was a contributing factor to a patient¿s death.

• Brand Name: OPERON D 860 SEAT, PHENOLIC, 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: 18145298
• MDR Text Key: 328222998
• Report Number: 0008010153-2023-00020
• Device Sequence Number: 1
• Product Code: GDC
• UDI-Device Identifier: 07613327170078
• UDI-Public: 07613327170078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OT 8601065
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/18/2023
• 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
• Patient Outcome(s): Death