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

Catalog Number MCM20

Device Problems Failure to Form Staple (2579); Mechanics Altered (2984)

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

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 9/6/2023 d4: batch # unk attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "please clarify how ¿the clips fell off first time¿ did clip not hold in tissue or vessel once placed? did device drop or eject clips? if other, please specify was there any issue with bleeding? if yes, what was the amount of the blood loss (mls)? was a transfusion required? was the procedure altered as a result of the event? what is the current patient status?" 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.

Event Description

It was reported that during a breast surgery, the clips fell off the first time, then apparently cut through the vein.Replaced with like device to complete procedure.

Manufacturer Narrative

(b)(4).Date sent: 10/3/2023.D4: batch # a9ce1g.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 mcm20 device was returned with a clip in jaws and with no apparent damage.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 9 clips as intended.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: ensure that a clip is in the jaws.Position the jaws so that the clip completely surrounds the vessel to be ligated.Fully squeeze the handles together until they stop.As the handles are squeezed, the clip closes and occludes the vessel or tubular structure.Fully release the handles to return the instrument to its original open position.The next clip is automatically advanced.Inspect the jaws after each clip application to ensure the presence of a new clip before applying the next clip.Repeat steps as necessary to continue ligation of tissue.For optimal performance, periodically clean the instrument during the procedure by submerging the jaw and distal end of the applier shaft in saline.The event described could not be confirmed as the device performed without any difficulties noted.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: 17689753
• MDR Text Key: 322716176
• Report Number: 3005075853-2023-06378
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002475
• UDI-Public: 10705036002475
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

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 Catalogue Number: MCM20
• Device Lot Number: 349C28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1