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 Collision (1429)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the table cable base came down on a surgeon's foot during a case.It was stated that the table leg section came into contact with instrument table just before incident where table base lifted up and came in contact with surgeon toe.This resulted in a broken toe which required medical intervention.
Event or Problem Description
It was reported that the table cable base came down on a surgeon's foot during a case.It was stated that the table leg section came into contact with instrument table just before incident where table base lifted up and came in contact with surgeon toe.This resulted in a broken toe which required medical intervention.
Additional Manufacturer Narrative
It was reported "(b)(6), technician, called in to report that d830 table (sn: (b)(6)) cable base came down on a surgeon's foot during a case.Delay in case for patient and user - unsure of how long a delay.Injury to the surgeon's foot.Broken toe.Customer stated that table leg section came into contact with instrument table just before incident where table base lifted up and came in contact with surgeon toe." a stryker field service technician was sent out on (b)(6) 2024 to perform repairs on the table.It was found that "inspect the table.Pull up eror log.Only recorded errors in log are for power on of table 'event power up first time', operate all table functions.Found leg section not properly seated on to leg spars, re-seat leg section and operate all table functions.All functions perfromed as designed and no noticable abnormalities is operation noted.Customer stated that table leg section came into contact with instrument table just before incident where table base lifted up and came in contact with surgeon toe.".During this repair it was found that the leg section was not properly attached to the table and the customer noted that the leg section hit an instrument table during the procedure.A review of the device history was completed.According to the manufacturing dhr, the table was manufactured on 25 apr 2019 and met quality specifications prior to shipment.There was no repairs needed on the table, but the leg section was reattached due to contact with outside equipment.The technician resolved the issue and recommended the table be placed back into service after completing their investigation.This issue was discovered during a case, and there was patient impact/involvement and a delay in surgery reported.This failure mode has not exceeded any threshold and will continue to be monitored per dwi2003.The root cause of the issue was found to be collision with equipment in the operating room that led to unintended movement of the table.If further information is obtained a supplemental will be filed.

• 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: 20800692
• Report Number: 0008010153-2024-00019
• Device Sequence Number: 8269823
• Product Code: GDC
• UDI-Device Identifier: 07613327169997
• UDI-Public: 07613327169997
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2019
• 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