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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ENSEAL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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ETHICON ENDO-SURGERY, INC. ENSEAL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number NSLG2C45A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/17/2018
Event Type  malfunction  
Event Description
The patient was undergoing a robotic prostatectomy when the enseal handpiece malfunctioned while being used.The enseal was removed and upon inspection it was noted the tip was not closing properly.The device worked through 75% of the procedure before malfunctioning.A new device was opened and the procedure was completed using the second device.The device was returned to the vendor who was present during the procedure.
 
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Brand Name
ENSEAL
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC.
4545 creek road
cincinnati OH 45242
MDR Report Key7482715
MDR Text Key107219102
Report Number7482715
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/27/2018
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 Physician
Device Expiration Date01/31/2023
Device Catalogue NumberNSLG2C45A
Device Lot NumberR92A5L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2018
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/27/2018
Event Location Hospital
Date Report to Manufacturer04/27/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age66 YR
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