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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ULTRACISION** HARMONIC SCALPEL** HAND PIECE; INSTRUMENT, ULTRASONIC SURGICAL

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ETHICON ENDO-SURGERY, LLC. ULTRACISION** HARMONIC SCALPEL** HAND PIECE; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Catalog Number HP054
Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The handpiece was received with the nose cone cracked and the mount was noted to be loose.No functional testing could be performed due to the nose cone was extremely cracked and no instrument could be attached to the handpiece.The instrument was disassembled to inspect internal components.The moisture indicator was positive.The transducer assembly was not held in place due to the cracked nose cone, so torquing on the disposable resulted in twisting only the handpiece transducer assembly until the internal wires got disconnected.Due to the cracked nose cone, moisture entered the hand piece mid housing.A possible cause of the nose cone being cracked is the sterilization method due to the heating and cooling of the sterilization cycles is a stressor.It is possible that the ingress of moisture affected handpiece functionality.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
 
Event Description
It was reported that prior to a total laparoscopic hysterectomy bilateral salpingo-oophorectomy procedure during initial set up the device would not connect to the instrument.The stud mount is loose and turns freely within the housing.The procedure was completed with another device of the same product code.There were no patient consequences reported.
 
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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 Key6059937
MDR Text Key58527704
Report Number3005075853-2016-06112
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002906
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 09/28/2016
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 NumberHP054
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/18/2016
Initial Date FDA Received10/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
GENERATOR
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