MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Model Number ER320

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # u9481g.Investigation summary: the er320 device was returned for analysis and upon inspection, the jaws were found to be in a yielded condition.In an attempt to replicate the reported incident, the device was functionally evaluated.Upon firing the device, the remaining 13 clips were ejected due to the condition of the jaws.Finally, the instrument locked out as intended.Possible causes for the device condition may be due to device being closed over an existing hard object or clip, placing stress on the jaws and 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.The reported complaint was confirmed.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.It is known from the history of the device that the condition of the jaws may lead to dropping/ejected clips.Please reference the instruction for use for more information.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a laparoscopic appendectomy, the device was dropping clips.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10715018
• MDR Text Key: 212490286
• Report Number: 3005075853-2020-05457
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1