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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP CLIP APPLIER; CLIP, IMPLANTABLE
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ETHICON ENDO-SURGERY, LLC. LIGACLIP CLIP APPLIER; CLIP, IMPLANTABLE Back to Search Results
Catalog Number ER320
Device Problems Bent (1059); Mechanical Problem (1384); Failure to Form Staple (2579)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/27/2015
Event Type  malfunction  
Event Description
It was reported that during a laparoscopic colon procedure; the clips were not forming at all, one leg long, the other slightly bent.The procedure was completed using same like device.No adverse patient consequences were reported.
 
Manufacturer Narrative
(b)(4).No device received for analysis at time of submission of 3500a.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.
 
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Brand Name
LIGACLIP CLIP APPLIER
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo PR 0096 9
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 0096 9
Manufacturer Contact
milton garrett
5133378865
MDR Report Key4859611
MDR Text Key18786096
Report Number3005075853-2015-03830
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K864102
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/08/2015
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 NumberER320
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/08/2015
Initial Date FDA Received06/22/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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