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

Catalog Number	OT 8602065
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the table moved unexpectedly.They were putting the table in reverse mode and when they moved it, the table jerked.The doctor had been holding a camera under the kidney when it happened and it pierced the kidney which required medical intervention.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
On 7 dec 2023, it was e-mailed in stating table (a11934) moved unexpectedly, needs tech to investigate.They were putting the table in reverse mode and when they moved it, the table jerked.The doctor had been holding a camera under the kidney when it happened and it pierced the kidney.A stryker field service engineer was dispatched to investigate and responded on 7 dec 2023.During this investigation, it was found that the hand pendant was intermittent, but the issue was not replicated.Based on information gathered from the first field service investigation, the field service engineer was sent out again on 20 dec 2023.During the second investigation, there were images taken of the underside of the leg section as well as another 10 cycles of testing.The second investigation was performed to determine if the issue could not be replicated as well as to see if a potential cause of the issue would be objects placed underneath the table.Based on the information that was gathered from the field service engineer, a potential root cause of this issue is the placement of objects underneath the table.This can be seen within some of the damage to the underside of the leg section of the table.This issue could not be replicated and therefore it cannot be confirmed that the issue was caused by placing objects on the underneath base of the table.This issue was discovered during a medical procedure, and there was patient impact and an adverse event reported.This failure mode has not exceeded any threshold and will continue to be monitored per dwi2003.If further information is obtained a supplemental will be filed.
Event or Problem Description
It was reported that the table moved unexpectedly.They were putting the table in reverse mode and when they moved it, the table jerked.The doctor had been holding a camera under the kidney when it happened and it pierced the kidney which required medical intervention.

• 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: josh phillips ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 18440129
• Report Number: 0008010153-2024-00001
• Device Sequence Number: 20778558
• Product Code: GDC
• UDI-Device Identifier: 07613327170160
• UDI-Public: 07613327170160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/22/2024

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 8602065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 03/22/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown