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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE
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ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE Back to Search Results
Catalog Number ER420
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
 
Event Description
It was reported that during an unknown procedure, the trigger was not returned to the home position at the firing.Another device was used to complete the case.There were no adverse consequences to the patient.
 
Manufacturer Narrative
(b)(4) mdr decision: not reportable.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.Additional information: the procedure was laparoscopic colectomy.The trigger was returned to home position manually.
 
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Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key7357048
MDR Text Key103218565
Report Number3005075853-2018-08661
Device Sequence Number1
Product Code FZP
UDI-Device Identifier20705036012594
UDI-Public20705036012594
Combination Product (y/n)N
PMA/PMN Number
K864102
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberER420
Device Lot NumberK4CE3T
Was Device Available for Evaluation? No
Date Manufacturer Received03/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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