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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP* APPLIER W/MECH STOP; APPLIER, SURGICAL, CLIP
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ETHICON ENDO-SURGERY, LLC. LIGACLIP* APPLIER W/MECH STOP; APPLIER, SURGICAL, CLIP Back to Search Results
Catalog Number LX207
Medical Device Problem Codes Mechanical Problem (1384); Failure to Form Staple (2579)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Date of event is 2021.Event day and event month were not reported.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.
 
Event or Problem Description
It was reported that during an unknown procedure, the device had lack of bite and faulty clip formation.It is unknown how the procedure was completed.Patient consequence was not reported.
 
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Common Device Name
APPLIER, SURGICAL, CLIP
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
*  00969
MDR Report Key12285574
Report Number3005075853-2021-04532
Device Sequence Number4725112
Product Code GDO
UDI-Device Identifier10705036012894
UDI-Public10705036012894
Combination Product (Y/N)N
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/16/2021
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
Operator of Device Health Professional
Device Catalogue NumberLX207
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/16/2021
Initial Report FDA Received Date08/05/2021
Patient Sequence Number1
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