MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG OR-TABLE OPERON D 820 W/O LEG PLATE, US-RAIL, 120V W/O POWER DRIVE, PHENOLIC; TABLE, OPERATING-ROOM, ELECTRICAL

Catalog Number OT 8204575

Device Problems Unintended Collision (1429); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

It was reported that while a patient was on the table and table pendant button was pushed and released and the table allegedly kept moving.It was reported that an employee was hurt by the table lowering with her foot under the table.The employee was admitted to the er for diagnostics, x-ray and ct scan and discharged home the same day.The table has been returned and is currently being investigated by stryker quality engineers.A supplemental filing will be filed if and when the investigation is completed.

Event Description

It was reported that while a patient was on the table and table pendant button was pushed and released and the table allegedly kept moving.It was reported that an employee was hurt by the table lowering with her foot under the table.The employee was admitted to the er for diagnostics, x-ray and ct scan and discharged home the same day.

Manufacturer Narrative

A capa was initiated to further investigate the reported event of the reported unintended movement.Through investigation, the tables were found to meet design specifications.Within the capa there are multiple potential root causes which may have attributed to this complaint.As a result, each potential root cause was assessed and action have been taken to prevent future occurrences as related.Also through investigation, along with multiple consultations with physicians, it was determined that the risks involved with this event has a limited severity and a negligible occurrence of harm associated with it.No injuries have been reported as a result of unintended movement of the surgical table and it is unlikely that any injuries would result if this event were to reoccur.

Event Description

It was reported that while a patient was on the table and table pendant button was pushed and released and the table allegedly kept moving.It was reported that an employee was hurt by the table lowering with her foot under the table.The employee was admitted to the er for diagnostics, x-ray and ct scan and discharged home the same day.

• Brand Name: OR-TABLE OPERON D 820 W/O LEG PLATE, US-RAIL, 120V W/O POWER DRIVE, PHENOLIC
• Type of Device: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532
• Manufacturer Contact: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; 74611810
• MDR Report Key: 5051239
• MDR Text Key: 24891438
• Report Number: 0008010153-2015-00029
• Device Sequence Number: 1
• Product Code: GDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: OT 8204575
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other