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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX TELEFLEX LAPAROSCOPIC LIVER RETRACTOR

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TELEFLEX TELEFLEX LAPAROSCOPIC LIVER RETRACTOR Back to Search Results
Catalog Number 728148
Device Problems Break (1069); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2018
Event Type  Injury  
Event Description
During a laparoscopic cholecystectomy one blade of a teleflex laparoscopic fan retractor catalog #728148 broke off of the retractor and fell into the patient's abdominal cavity. The piece was immediately retrieved by the surgeon and all pieces were accounted for. The retractor and broken blade were retained for inspection if necessary.
 
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Brand NameTELEFLEX
Type of DeviceLAPAROSCOPIC LIVER RETRACTOR
Manufacturer (Section D)
TELEFLEX
limerick PA
MDR Report Key7305675
MDR Text Key101499283
Report NumberMW5075601
Device Sequence Number1
Product Code PKE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number728148
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/28/2018 Patient Sequence Number: 1
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