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

Model Number MCS20

Device Problem Failure to Form Staple (2579)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.

Event Description

It was reported that during a ventral midline coeliotomy procedure, a ligature was placed on hepatic vein and then placed clips with our ligaclips, however most of the clips were fired and turned out the clips incompletely closed.It is unknown how the procedure was completed.There was no patient consequence.

Manufacturer Narrative

(b)(4).Date sent: 12/16/2020.D4: batch # t94239.H6: component code: others (g07).Investigation summary: the analysis results found that the mcs20 device was received empty.In addition, three properly formed clips and one unformed clip were received stuck on a paper.After the last clip is used, the instrument is designed to lock out, which prevents the handles from being squeezed; therefore a potential cause of the customer reported experience is the firing of all of the clips and the instrument "will not fire" (activation of the lock out mechanism).Due to the condition of the device, no functional testing could be performed to evaluate the incident reported.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.No conclusion could be reached as to what may have caused the reported incident as the device was returned empty.The reported complaint could not be confirmed.Although there is no direct evidence of use error, the instructions for use do contain the following caution: the remaining clips are visible through the back of the clip applier shaft.A yellow clip indicator follows the last clip and advances with it down the shaft.This provides a visual reference of the quantity of clips remaining.When no clips remain in the instrument, the safety lock out mechanism prevents the handles from being squeezed.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.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10836962
• MDR Text Key: 216219904
• Report Number: 3005075853-2020-05982
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002499
• UDI-Public: 10705036002499
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Date Manufacturer Received: 11/27/2020
• Patient Sequence Number: 1