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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ROTATING MULTIPLE CLIP APPLIER; CLIP, IMPLANTABLE
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ETHICON ENDO-SURGERY, LLC. ROTATING MULTIPLE CLIP APPLIER; CLIP, IMPLANTABLE Back to Search Results
Catalog Number ER320
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2014
Event Type  malfunction  
Event Description
It was reported that during a laparoscopic cholecystectomy procedure, the clips would not feed into the jaws.It was also reported the clips would not squeeze.No additional information was available.Another device was used to complete the procedure.There was no patient consequence.The device was discarded.
 
Manufacturer Narrative
(b)(4).Device was not returned for evaluation.
 
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Brand Name
ROTATING MULTIPLE 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
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key4172764
MDR Text Key5021339
Report Number3005075853-2014-07087
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberER320
Device Lot NumberL4F31N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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