MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG OPERON D 830 SEAT PHENOLIC STAINLESS; TABLE, OPERATING-ROOM, ELECTRICAL

Catalog Number	OT 8301065
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the staff lowered their table on a stool which lifted the base off the ground.When the stool gave out, the table landed on a staff members foot.The user was sent to get xrays on their foot.Complainant was not aware of x-ray results or if further treatment or medical intervention was required.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the staff lowered their table on a stool which lifted the base off the ground.When the stool gave out, the table landed on a staff members foot.The user was sent to get xrays on their foot.Complainant was not aware of x-ray results or if further treatment or medical intervention was required.
Additional Manufacturer Narrative
On 9 may 2024, it was reported "that the staff lowered their d830 table on a stool which lifted the base off the ground.When the stool gave out, the table landed on a staff members foot".The main incident reported was caused by the stool underneath the table, this type of use is not following the operator's manual.The damage done to the table has yet to be repaired.This issue was discovered during usage, and there was patient involvement, but complainant was not aware of x-ray results or if further treatment or medical intervention was required.This failure mode has not exceeded any threshold and will continue to be monitored.The root cause of the issue could be that there was object located in the direction of movement of the or-table during its movements which led to the problem.

• Brand Name: OPERON D 830 SEAT PHENOLIC 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: josh phillips ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 19492936
• Report Number: 0008010153-2024-00012
• Device Sequence Number: 7037219
• Product Code: GDC
• UDI-Device Identifier: 07613327169997
• UDI-Public: 07613327169997
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 10/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: OT 8301065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown