MAUDE Adverse Event Report: UNKNOWN BECKMAN-ADSON; RETRACTOR

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2016

Event Type  malfunction  

Event Description

The surgeon asked to use the adson beckman retractor.After 5 minutes of use one of the retractor arms fell into the incision.It was then discovered by surgeon and scrub tech that a screw was missing from the retractor arm.This screw held the retractor arm and allowed for the toothed section to bend.An ap x-ray was immediately obtained of the incision site.Radiologist was notified and agreed with surgeon that the retractor screw was not in the incision.Surgery proceeded and another ap x-ray was obtained at the end of the case.Single frontal view of spine and single view of abdomen performed; no unexpected radiopaque foreign body is identified.

• Brand Name: BECKMAN-ADSON
• Type of Device: RETRACTOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6793921
• MDR Text Key: 82678060
• Report Number: 6793921
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.
• Patient Age: 36 YR