MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO MED CLIP APPLIER; APPLIER, HEMOSTATIC CLIP

Catalog Number	EL214
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary the analysis results confirmed that the el214 device was returned nonfunctional as jaws were found to be in a yielded condition; therefore, the clips could not be loaded into the jaws.Possible causes for this condition may be if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel.Please note that as stated in the ifu: "all surgical instruments are subject to a degree of wear and tear because of normal use.A regular and precise visual check of the instrument should be made before each use.In addition, a photo was received for review.Upon visual inspection of the photo, the following was observed: the photo showed a device with the serial number of (b)(4).Based on the photo alone, the event described could not be confirmed.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.
Event or Problem Description
It was reported that during an unknown procedure, the clip was not properly fitted into the clip applier.It is unknown how the procedure was completed.The was no patient consequence.

• Common Device Name: APPLIER, HEMOSTATIC CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 10022576
• Report Number: 3005075853-2020-02481
• Device Sequence Number: 3053028
• Product Code: HBT
• UDI-Device Identifier: 10705036003847
• UDI-Public: 10705036003847
• Combination Product (Y/N): N
• PMA/510(K) Number: K830503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EL214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/04/2020
• Patient Sequence Number: 1