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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
Model Number ER320
Device Problems Mechanical Problem (1384); Failure to Form Staple (2579)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to obtain additional information and to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent: please clarify " the jaw overlaps", was the jaw misaligned ? if other, please specify.Please provide the status of the device(s) as it has not been received for analysis.
 
Event Description
It was reported that during an unknown procedure, the clips "get out like x shape from the jaw overlaps.Surgeon used oversewing technique instead of clip applier.There was no patient consequence.
 
Manufacturer Narrative
(b)(4).Date sent: 1/15/2021.H2: additional information received: there were only two items of issue for this event (reported first device on mwr-16122020-0000862176 and second device on mwr-16122020-0000862177).There was no third device that had a quality issue.See corrected data in d11 for third device.Per additional information received (see h10), there were only two items of issue for this event (first device reported on mwr-16122020-0000862176 and second device reported on mwr-16122020-0000862177).There was no third device that had a quality issue.Upon review of this additional information provided in h10, it was concluded that as there was no third device of issue for this event, therefore event for a third device does not meet the fda defined criteria for a reportable event and is being considered not reportable/void.
 
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Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key11033744
MDR Text Key222811411
Report Number3005075853-2020-06975
Device Sequence Number1
Product Code FZP
UDI-Device Identifier10705036012580
UDI-Public10705036012580
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 11/24/2020
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 Model NumberER320
Device Catalogue NumberER320
Device Lot NumberU4063Y
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/24/2020
Initial Date FDA Received12/17/2020
Supplement Dates Manufacturer Received12/24/2020
Supplement Dates FDA Received01/15/2021
Patient Sequence Number1
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