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

Model Number ER420

Device Problems Failure to Form Staple (2579); Failure to Fire (2610)

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

Event Date 11/23/2022

Event Type  malfunction  

Event Description

It was reported that during a tapp procedure, the device got stuck after about 4 triggers.After that, the clip came out deformed.No patient harm nor significant delay reported.

Manufacturer Narrative

(b)(4).Batch # unk.Additional information was requested and the following was obtained: "were there any patient consequences? if yes, please describe.As written in the complaint description no".A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 1/24/2023.D4: batch # x94t9d.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the er420 device was returned with no apparent damage.In addition, one malformed clip was returned inside the plastic bag along with the instrument.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled and it fed and formed the remaining 15 clips as intended.However, the lockout mechanism was found to be non-functional.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, the latch posts were found to be broken which suggest that a lockout premature occurred and leading the incident reported.Possible cause of the found condition may be that during the activation of the trigger it was not completely released to home position when the next firing sequence was initiated.In order to avoid this kind of issue please note that the instrument should be fully squeezed on each firing.A ¿click¿ is heard and until you touch plastic trigger to plastic handle (plastic to plastic).Fully release the trigger after firing.A second ¿click¿ should be heard indicating the instrument is ready for the next firing.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16009254
• MDR Text Key: 308204624
• Report Number: 3005075853-2022-08774
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

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 Number: ER420
• Device Catalogue Number: ER420
• Device Lot Number: X94W41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1