MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG OR TABLE OPERON D850 W/POWER DRIVE UNIT, USA VERSION; TABLE, OPERATING-ROOM, ELECTRICAL

Catalog Number OT 1701175

Device Problem Unintended Head Motion (1284)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

It was reported that the head section allegedly was drifting downward.The head section is being returned to stryker for evaluation.When stryker can perform the evaluation on the head section, a supplemental will be filed to include the investigation results.There was no patient involvement, injury or adverse consequence reported.Product requested, but not yet received.

Event Description

It was reported that the head section allegedly was drifting downward.There was no patient involvement, injury or adverse consequence reported.

Manufacturer Narrative

The original mdr reported the serial number as unknown, but through the investigation, it was found to be (b)(4).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 the head section allegedly was drifting downward.There was no patient involvement, injury or adverse consequence reported.

• Brand Name: OR TABLE OPERON D850 W/POWER DRIVE UNIT, USA VERSION
• 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: 6106680
• MDR Text Key: 60039792
• Report Number: 0008010153-2016-00102
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OT 1701175
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: No
• 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