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

Model Number ER420

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: t94h1k.Date of event is 2020.Event day and event month were not reported.(b)(4).Investigation summary: the analysis results of the er420 device found that it was returned with no damage to the external components and with a clip in the jaws.The clip was removed in order to inspect the jaws and they were found to be yielded, misaligned.In an attempt to replicate the reported incident, the device was tested for functionality.During the analysis, the device was cycled and it fed and formed four scissored clips.In addition, the device locked out as intended.Although it is not possible to conclude how the circumstances occurred, it is known from the history of the instrument that an incorrect/excessive application of torque to the jaws during instrument use creates a misalignment of the tips.In addition, as per the instructions for use ¿do not excessively twist or torque the instrument jaws when positioning the instrument on a vessel and firing.Excessive twisting or torquing may result in clip malformation.¿ please reference the instruction for use for more information.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Attempts were made to obtain additional information.To date, no additional information has been received.If further details are received at a later date, a supplemental medwatch will be sent: please clarify how the ¿reload can not formation¿.Did device not feed clips? did device not fire clips (jammed)? did device fire malformed clips? did device fire scissored clips? did device drop or eject clips? were there any patient consequences? if yes, please describe.

Event Description

It was reported that during an unknown procedure, when using er420, "reload cannot formation." it is unknown how procedure was completed.Patient consequence was not reported.

• 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 ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 11008171
• MDR Text Key: 221487010
• Report Number: 3005075853-2020-06790
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Device Lot Number: T94N81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1