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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
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SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Device Problem Component Missing (2306)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/15/2021
Event Type  malfunction  
Event Description
Patient had a repeat cesarean section with bilateral tubal ligation at 32 weeks for severe preeclampsia. After second count, scrub tech noted that the tip of a needle driver was missing. Mds, circulating nurse, and charge nurse notified immediately. Surgical team checked around sterile field, but could not find the missing tip. Patient closed up and brought out to pacu (post anesthesia care unit) for recovery. Md and anm (assistant nurse manager) at bedside to notify patient and family about the possibility of the missing needle driver tip being retained during surgery and that she will receive an x-ray at bedside to determine if it was retained. Patient and husband verbalized understanding. X-ray technician came to bedside, results were read by md. Md came to bedside to notify patient and support person that nothing was seen on the x-ray. Patient and husband verbalized understanding. This device is a consumable and the instrument involved is not maintained by clinical engineering. No further action required by clinical engineering.
 
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Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
MDR Report Key12134311
MDR Text Key260474773
Report Number12134311
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2021
Event Location Hospital
Date Report to Manufacturer07/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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