MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG OPERON D 850 WITH; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	OT 1702075
Medical Device Problem Codes	Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 22 march 2023, stryker tech support received a complaint from a customer ochsner baptist med in new orleans, la and opened sfdc case# 12595269.Stryker tech support documented the following: ¿(b)(6).Called in stating the d850 table (s/n: (b)(4) ) stopped working in the middle of a case.The power light is still flashing showing a fully charged battery.Marvin checked both hand pendants and tried to use the table both in the aux and primary pendant connection.They were able to unlock the table with the button in the base to get it out of the or, but have not been able to get any response from either pendant.He tested the pendants on another table and they both worked fine.The patient was open and they had to close the patient and reschedule the surgery for a later date.¿ a stryker field service technician (sfst) was dispatched and arrived at the facility on 27 march 2023.The sfst completed an adverse event form on 28 march 2023 and inspected the operon surgical table.The sfst confirmed the serial number of the device as an operon d850 with sn (b)(4).The sfst completed the inspection and reported ¿per customer, table was unresponsive even while plugged in.Further investigation found that something was loose under the base cover because the table would flicker on and off as i moved the base cover around.Wiggled the base cover enough to keep the table power on while it was plugged in and able to attach straps to the base cover to lift and expose the table base electronics.Visual inspection found the power supply cover was not attached correctly to the table base.The lip of the cover was screwed to the outside of the table base and not to the inside as designed.While the power supply cover was covering the power supply, it wasn't secured properly and was missing a screw.I suspect that the cover crushed the connectors connecting power to the table due to weight being applied to the base under foot or other means and applying pressure to the connectors on the power supply.Once i removed the cover, i was able to operate the table normally.Inspection of the power supply found loose connector bases on the power supply board, including the psb is bent/cracked.Further, while plugged into gui there are repeated mcu errors that do not stop registering and battery check found that the batteries will not hold a charge.Recommend that the psb, cpu and batteries all be replaced.The customer was advised to complete the recommended repairs.A po was requested.Although the exact root cause of this issue is unknown, based on the information provided, the most likely root cause would be expiration of the useful life of the batteries and/or a short in the power supply after mis assembly by the customer.This issue has not exceeded any thresholds and will continue to be monitored per dwi2003.The investigation is still in progress.If further information is obtained a supplemental will be filed.
Event or Problem Description
It was reported that the d850 table stopped working in the middle of a case.The patient was open and they had to close the patient and reschedule the surgery for a later date.

• Brand Name: OPERON D 850 WITH
• 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: 16765894
• Report Number: 0008010153-2023-00010
• Device Sequence Number: 14998042
• Product Code: GDC
• UDI-Device Identifier: 07613327169874
• UDI-Public: 07613327169874
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 04/18/2023

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 Model Number: OT 1702075
• Device Catalogue Number: OT 1702075
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/18/2023
• 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