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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 ER320
Device Problems Component Falling (1105); Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).As a lot/batch was not provided, a device history could not be performed.
 
Event Description
It was reported that the surgeon experienced problems with the device during a lap chole case.The problem was described as ¿clips falling off, loose, falling out of applier etc.¿ the involved device was not retained.Subsequent cases performed with devices from a different lot have been normal with no problems.There were no patient consequences.
 
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Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
Manufacturer Contact
milton garrett
475 calle c
guaynabo 00969
5133378865
MDR Report Key7406309
MDR Text Key105258902
Report Number3005075853-2018-09005
Device Sequence Number1
Product Code FZP
UDI-Device Identifier20705036012587
UDI-Public20705036012587
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 health professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberER320
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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