MAUDE Adverse Event Report: HOLGER ULLRICH ACCESSORIES UNIVERSAL; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 100323C0 - RADIAL SETTING CLAMP

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 08/08/2019

Event Type  Injury  

Event Description

The following was reported.An anesthesia frame was mounted to an operating table by using a radial setting clamp.The anesthesia frame fell on the patient's head and caused a wound which had to be stitched.Manufacturing reference # (b)(4).

Manufacturer Narrative

As a result of an internal review, it was found that the importer aware date was inadvertently omitted.

Event Description

Manufacturing reference #: (b)(4).

Event Description

Manufacturing reference #: (b)(4).

Manufacturer Narrative

The affected clamp was returned to the factory for investigation.A functional test was performed with the affected clamp.It was mounted to a maquet side rail and fixed by fastening the drop toggle screw.The firm seat was checked afterwards and found to be alright.Next an accessory was attached to the radial setting clamp as described in the instructions for use (ifu).The firm seat was checked and found to be alright, too.The dimensions of the side rail which was used when the incident occurred were requested.They were provided, checked and found to be within the range specified in the ifu.The same was done for the weight of the used anesthesia frame.It was checked and found to be within the range specified in the ifu.The malfunction described by the user could not be reproduced at the manufacturer site.Therefore we assume a use error as the most probable root cause for this issue.We assume that one of the securing elements was not fastened properly.In the ifu it is described how the clamp is fixed on the side rail and how accessories are fixed on the clamp.Further the user is warned as follows concerning the risks related to loosened securing elements: ".Loose or loosened securing elements may cause injuries.When mounting, and after every adjustment, tighten all of the locking elements (handle screw, locks, levers, etc.) of the product.Check the firm seating of the locking elements." in the course of the investigation two cracks were found on the radial setting clamp.In the performed tests, these cracks had no impact on the correct function of the product.In the ifu the user is told to perform a visual and functional inspection prior to use to ensure correct operation.Besides she or he is told not to use a defective product.Maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: ACCESSORIES UNIVERSAL
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 8907221
• MDR Text Key: 154761712
• Report Number: 3013876692-2019-00014
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100323C0 - RADIAL SETTING CLAMP
• Device Catalogue Number: 100323C0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2019
• Distributor Facility Aware Date: 11/13/2019
• Date Report to Manufacturer: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other