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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY LLC LIGACLIP 10-M/L / 10MM ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIERS; CLIP APPLIER SURGICAL
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ETHICON ENDO-SURGERY LLC LIGACLIP 10-M/L / 10MM ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIERS; CLIP APPLIER SURGICAL Back to Search Results
Model Number ER320
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Abdominal Pain (1685)
Event Date 09/14/2018
Event Type  Injury  
Event Description
Pt went to operating room for laparoscopic cholecystectomy on (b)(6) 2018.Operation appeared normal and pt went home.Pt returned to the hospital on 20 abdominal pain.Pt back to operating room on (b)(6) for a bile leak.Pt had a diagnostic laparoscopy with irrigation and wash out done.Drain placed.Operating room leadership are questioning the effectiveness of the laparoscopic clip applier.They say they have had several other very similar events over the past six weeks.Same procedure and same complication.Later all three of our surgeons agreed they were each having this problem recently and not previously.
 
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Brand Name
LIGACLIP 10-M/L / 10MM ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIERS
Type of Device
CLIP APPLIER SURGICAL
Manufacturer (Section D)
ETHICON ENDO-SURGERY LLC
guaynabo PR 00969
MDR Report Key8079080
MDR Text Key127612005
Report NumberMW5081384
Device Sequence Number1
Product Code GDO
UDI-Device Identifier20705036012587
UDI-Public(01)20705036012587
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2023
Device Model NumberER320
Device Catalogue NumberER320
Device Lot NumberR40F35
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age57 YR
Patient Weight74
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