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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENSEAL ELECTROCAUTERY

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ETHICON ENSEAL ELECTROCAUTERY Back to Search Results
Model Number NSLG2C35A
Device Problem Peeled/Delaminated (1454)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/14/2017
Event Type  Injury  
Event Description
Laparoscopic hysterectomy using ethicon enseal tissue sealer. Black insulation peeled off during surgery in patient's abdomen and was discovered by surgeon, and then removed from abdominal cavity.
 
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Brand NameENSEAL
Type of DeviceELECTROCAUTERY
Manufacturer (Section D)
ETHICON
blue ash OH 45242
MDR Report Key6507410
MDR Text Key73386849
Report NumberMW5069202
Device Sequence Number1
Product Code HGI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model NumberNSLG2C35A
Device Lot NumberP9164D
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: 04/18/2017 Patient Sequence Number: 1
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