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	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that an operon d860 surgical table with serial number (b)(4), when articulating into a trendelenburg position, had the back section become disengaged.The back section was resecured and the procedure was completed without further incident.After further consultation with the customer it was determined that the patient¿s organs were exposed during the alleged incident.A stryker field service technician (sfst) was dispatched, inspected the table, and found the back section was connected properly and at that time there were no issues with the table.After further inspection it was determined that the reported issue experienced is due to wear/damage of the channels of the detachable back section.A new back section was ordered for the customer.On 28mar2022 the back section was received and replaced by the customer.There was patient involvement during the alleged incident due to the issue occurring during a procedure, however there was no reported injuries or adverse consequences to the patient or staff.A review of the device history record (dhr) was completed.There were no failures noted during the manufacturing or final quality inspection process.The most probable root cause for this alleged incident is normal wear of the back section.
Event or Problem Description
It was reported the back section of the d860 table came off when putting it into the trend position.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: 14117602
• Report Number: 0008010153-2022-00007
• Device Sequence Number: 17226980
• Product Code: GDC
• UDI-Device Identifier: 07613327170160
• UDI-Public: 07613327170160
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/15/2022

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: 03/24/2022
• Initial Report FDA Received Date: 04/15/2022
• 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