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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE + 7; INSTRUMENT, ULTRASONIC SURGICAL

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ETHICON ENDO-SURGERY, LLC. HARMONIC ACE + 7; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Catalog Number HARH36
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Information unavailable.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.
 
Event Description
It was reported that during a right salpingo-oophorectomy procedure, the tissue pad was coming loose during the procedure.The surgeon removed the device from the patient as soon as the issue was noticed.The tissue pad fell off the device outside of the patient and the tissue pad was discarded.The tissue pad did not fall into the patient and did not need to be retrieved.Another like device was used to complete the procedure.There were no adverse consequences for the patient.
 
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Brand Name
HARMONIC ACE + 7
Type of Device
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo PR 00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 00969
Manufacturer Contact
milton garrett
4545 creek road ml 120a
cincinnati, OH 45242
5133378865
MDR Report Key5615867
MDR Text Key44615422
Report Number3005075853-2016-02374
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132612
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberHARH36
Device Lot NumberN9043C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/08/2016
Initial Date FDA Received04/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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