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

Model Number MCS20

Device Problem Difficult to Open or Close (2921)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Additional information was requested and the following was obtained: 1.Was device stuck on tissue when it would not open? if yes, was there any damage to the tissue? yes device was stuck on tissue and could not open.Slight damage to tissue 2.What was done to repair any damage to the tissue? slight damage, not much repair needed.Used a bipolar to zap any small bleeders.3.Was device ever able to be opened? yes.4.How was the device removed from the tissue/vessel it was on? used forceps / instruments to slowly pry open the jaws a manufacturing record evaluation is pending.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 an unknown procedure, the jaws of the clip applier, mcs20, were stuck after firing and the closed jaws did not open.No patient consequences.

Manufacturer Narrative

(b)(4) date sent: 10/27/2022 d4: batch # x95622 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 mcs20 device was returned with no damage to the external components.In addition, the packaging opened was returned along with the instrument.In an attempt to replicate the reported event, the device was tested for functionality.Upon testing, the device was fired, and the clips did not advance into the jaw.The device was disassembled to evaluate the condition of the internal components and the feedbar was found damaged.9 clips were found inside the clip track.Although no conclusion could be reached on what caused the damage to the feed bar, it is possible that the device was clipped over a hard object resulting in higher force to fire, subsequently damaging the mechanism.Please note that the instructions for use 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.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 lot and batch 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: 15632175
• MDR Text Key: 307065274
• Report Number: 3005075853-2022-07049
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002499
• UDI-Public: 10705036002499
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K820837
• 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: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCS20
• Device Catalogue Number: MCS20
• Device Lot Number: 857A92
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1