MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG OPERON D860 SEATPHENOLICSTLESSPWRDRV; TABLE, OPERATING-ROOM, ELECTRICAL

Catalog Number	OT 8601165
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after incisions and trocars were set while putting the table into reverse trendelenburg position the table top was not moving into position.The foot end of the table was off the floor about 6-8¿.As it was attempted to level out the table, the table quickly returned to the floor.This caused the nurse to lose her balance and fall causing their knee to hit the floor.The patient had no injuries during this event and required no intervention.The procedure resumed without any other incidents.It was noted that equipment was under table¿s leg section.After that equipment was moved, no further issues occurred.The nurse had a bone bruise and a contusion on her knee.No intervention was done on her, but she will need follow-up on her healing.She was working the following day.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that after incisions and trocars were set while putting the table into reverse trendelenburg position the tabletop was not moving into position.The foot end of the table was off the floor about 6-8".As it was attempted to level out the table, the table quickly returned to the floor.This casued the nurse to lose her balance and fall causing their knee to hit the floor.The patient had no injuries during this event and required no intervention.The procedure resumed without any other incidents.It was noted that equipment was under table¿s leg section.After that equipment was moved, no further issues occurred.The nurse had a bone bruise and a contusion on her knee.No intervention was done on her, but she will need follow-up on her healing.She was working the following day.
Additional Manufacturer Narrative
It was reported "(b)(6) called in stating that the d860 table (s/n: (b)(6)) needs to be investigated after the table fell when they were doing trendelenburg and they hit something".A stryker service technician was sent out on 6 aug 2024 to perform an inspection and it was found "i completed a full inspection of table and could not find any damage.The table was not leaking any fluid and was fully functional as all functions were checked.I also checked the error logs and no errors were present." there were no additional issues with the table.There is a clear warning within the operator manual surgical mobile operating table models d 860, d 850, d 830, d 820, d770, d 760 (57445), "objects on the base cover" stating "objects lying on the base cover can end up against the telescoping column shields when the or table is being repositioned and cause damage to the covers and brackets inside the covers.1.Never place objects on the base cover." within the intake information it was noted that a stryker mistral air was under the table's leg section meaning there was something on the base of the table which is against the warning statement in the operators manual.This issue was discovered during surgery, and there was patient impact/involvement but no adverse event 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 user error due to going against the warning statements in the operator's manual.If any further information is obtained around this event, a supplemental will be filed.

• Brand Name: OPERON D860 SEATPHENOLICSTLESSPWRDRV
• 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: 20102121
• Report Number: 0008010153-2024-00015
• Device Sequence Number: 8572175
• Product Code: GDC
• UDI-Device Identifier: 07613327170177
• UDI-Public: 07613327170177
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: OT 8601165
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 11/11/2024
• 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
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 100 KG