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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC HARMONIC HD 100I SHEARS 36CM SHAFT LENGTH; INSTRUMENT, ULTRASONIC SURGICAL
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ETHICON ENDO-SURGERY, LLC HARMONIC HD 100I SHEARS 36CM SHAFT LENGTH; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Model Number HARHD36
Device Problems Melted (1385); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2021
Event Type  malfunction  
Event Description
While using the new laparoscopic harmonic for a liver resection, the device started to produce an error message saying that the tip needed to be cleaned.The surgical tech had been cleaning the tip regularly, so she and the surgeon inspected the tip and found the inner lining of the jaws had melted.The product was immediately removed and replaced and the reps from ethicon, were called for guidance.They believe that the device may have been activating for too long without tissue between the jaws.The item was taken by the representative for evaluation of the product.
 
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Brand Name
HARMONIC HD 100I SHEARS 36CM SHAFT LENGTH
Type of Device
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 00969
MDR Report Key11886441
MDR Text Key252701103
Report Number11886441
Device Sequence Number1
Product Code LFL
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 05/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHARHD36
Device Catalogue NumberHARHD36
Device Lot NumberU93169
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/13/2021
Event Location Hospital
Date Report to Manufacturer05/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age22265 DA
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