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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the d860 table (s/n: (b)(6) is moving into trend position at random on it's own.There was currently a patient on the table, but the surgeon decided to continue the case with this table.Per additional information received, the patient had an open incision.There were no reported injuries or adverse consequences.
Event or Problem Description
It was reported that the d860 table (s/n: (b)(6)) is moving into trend position at random on it's own.There was currently a patient on the table, but the surgeon decided to continue the case with this table.Per additional information received, the patient had an open incision.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
On (b)(6) 2023 it was called in stating the d860 table (s/n: (b)(6)) is moving into trend position at random on it's own.There is currently a patient on the table, but the surgeon has decided to continue the case with this table.I recommended moving the patient to a new table and taking this one out of service until the error could be resolved.They have tried swapping out the pendant and cable to no effect.Per additional information received, the patient had an open incision.There were no reported injuries or adverse consequences.A field service technician was sent out on (b)(6) 2023 and found no error code from (b)(6) 2023.The technician was able to operate the table using the original hand pendant with no issues.The hand pendant was shipped back to stryker flower mound for an additional quality inspection.During the quality inspection of the returned product, the only issue seen on the hand pendant was cosmetic defects including scratches and a missing clip.The root cause of the issue was not determined due to a lack of replication of the issue seen by the account.This issue was discovered during a medical procedure, but there was no patient impact or adverse events to the patient.This failure mode has not exceeded any threshold and will continue to be monitored per (b)(4).If further information is obtained a supplemental will be filed.

• 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: 18374804
• Report Number: 0008010153-2023-00024
• Device Sequence Number: 15403145
• Product Code: GDC
• UDI-Device Identifier: 07613327170160
• UDI-Public: 07613327170160
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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?: No
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 12/21/2023
• 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): Yes
• 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 Sex: Unknown