MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG OR-TABLE OPERON D 820 W/O LEG PLATE, US-RAIL, 120V W/O POWER DRIVE, PHENOLIC; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	OT 8204575
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the d820 table (s/n: (b)(4)) has been reported to drop intermittently when there is weight applied and they perform the level function.This has happened twice during the span of about 3 weeks.Neither patient was harmed, and neither was oversized.When the table was moved from different positions into 'level', the height dropped suddenly 4"-6".The initial reporter stated that the unintended movement occurred during a procedure after incision on one occasion.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
It was reported to stryker that during a case, an operon d820 with sn (b)(4) appears to be dropping intermittently when there is weight applied and the table level function is actuated.This type of occurrence was reported to occur two times over the course of 3 weeks.On both occurrences the staff commented that ¿neither patient was harmed and neither patient was oversized.¿ it was also reported that when the table was moved from different positions into ¿level¿, the height dropped suddenly 4-6 inches¿.A stryker field service technician (sfst) was dispatched for investigation and the customer put the case on hold until 8 aug 2022.During the initial visit, the sfst performed functional testing on the table with patient weight but was unable to duplicate the issue.The sfst contacted the initial reporter at the account to gather additional details regarding the patients.The initial reporter stated that the unintended movement occurred during a procedure after incision on one occasion.There was no report of patient injury or injury to staff nor was there a delay in surgery.Both the service records and the device history record (dhr) for the surgical table were reviewed.According to the dhr the table was manufactured in 2012.There were no failures noted during the manufacturing or final quality inspection process.The service ticket database was reviewed and there were no prior service tickets entered into the system for this table.Based on the staff interviews, the physical evidence, the dhr and service history reviews, and the field service investigation the exact root cause of the unintended motion is unknown.The most probable root cause would be collision of the table with other equipment in the room or user error.This case is still under investigation.As was reported, there was no adverse event or reported injury to either the patient or surgical staff.If further information is obtained, a supplemental will be filed.

• Brand Name: OR-TABLE OPERON D 820 W/O LEG PLATE, US-RAIL, 120V W/O POWER DRIVE, PHENOLIC
• 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: 15262923
• Report Number: 0008010153-2022-00009
• Device Sequence Number: 5542313
• Product Code: GDC
• UDI-Device Identifier: 07613327170009
• UDI-Public: 07613327170009
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/19/2022

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 8204575
• Device Catalogue Number: OT 8204575
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/19/2022
• 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