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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER ADSON BECKMAN; RETRACTOR
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BECKMAN COULTER ADSON BECKMAN; RETRACTOR Back to Search Results
Device Problem Component Missing (2306)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/15/2018
Event Type  malfunction  
Event Description
Patient underwent left radical adrenalectomy, resection left renal vein, and ivc tumor thrombus and right pulmonary artery thrombectomy about a week ago.During procedure, as surgeon was removing adson-beckman retractor used to expose the right pa, it was discovered that one yellow rubber shod was missing from the end of the retractor.(missing shod was noticed prior to surgical incision in the cardiac chamber and the pulmonary artery).The surgeon immediately identified that the yellow shod was missing and search of or room, table, etc.Was conducted.Drapes and towels also searched at end of case but the team was unable to locate the shod.Patient remained stable for the rest of case and was transferred to icu post-operatively without incident.The surgeon notified family of event.
 
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Brand Name
ADSON BECKMAN
Type of Device
RETRACTOR
Manufacturer (Section D)
BECKMAN COULTER
250 s kraemer blvd
brea CA 92821
MDR Report Key8037613
MDR Text Key126103843
Report Number8037613
Device Sequence Number1
Product Code GAD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/22/2018
Event Location Hospital
Date Report to Manufacturer11/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age25550 DA
Patient Weight57
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