MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX-5MM ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Model Number EL5ML

Device Problems Failure to Form Staple (2579); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/05/2021

Event Type  Injury  

Event Description

It was reported that during a laparoscopic cholecystectomy, when the clip was deployed, the clip cut off the target tissue and bleeding occurred.The device was used on the blood vessel.It seemed scissoring occurred.The procedure was converted to an open procedure to complete the case.

Manufacturer Narrative

(b)(4).Batch # v94l55.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined the el5ml device was returned with no apparent damage.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed twelve conforming clips.The first clip was dry fired and the remaining eleven clips were fired onto a test material.The surface of the clips was examined for burrs or sharp edges and no anomalies were found.Additionally, eleven clips were removed from the test material and no tears or cutting of the test material were observed.The jaws of the clip applier were also inspected and no burrs or sharp edges were observed.The event described could not be confirmed as the device performed without any difficulties noted and no product defect was identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following: "caution: do not excessively twist or torque the instrument jaws when positioning or firing the instrument on a tubular structure or vessel.Excessive twisting or torquing may result in clip malformation." as part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.Additional information received: "when the clip was deployed, the clip cut off the target tissue and bleeding occurred at the 2nd firing.The amount of bleeding was 250cc.No blood transfusion was required.Additional hand suture was performed to stop bleeding.The device was used on the cystic artery." the additional information provided above makes it unclear if procedure was able to be completed laparoscopically or if procedure was converted to an open procedure as was originally reported.Additional information has been requested (see below).If additional information is received at a later date that this procedure was not converted to an open procedure, a supplemental mw will be sent to downgrade reportability on this file: attempts are being 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: was the procedure converted to an open procedure? yes or no.If surgeon did not convert to open procedure, was surgeon able to control bleeding just by hand suturing? if surgeon converted to an open procedure: was procedure converted to open procedure due to el5ml issues that were described in the event? or was procedure converted to an open procedure due to patient related issue (and not a device issue)? was each clip loaded and inspected off vessel prior to applying clip to vessel for occlusion of vessel?.

Manufacturer Narrative

(b)(4).Date sent: 12/10/2021.H2: additional information received: affiliate reports that no procedure video was available.Affiliate also confirmed what was previously reported in the event description that procedure was converted to open procedure to control bleeding due to issues described in event.Affiliate also reports patient current status as "no problem for the patient.".

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• 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
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12756145
• MDR Text Key: 280455584
• Report Number: 3005075853-2021-06668
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• PMA/PMN Number: K050344
• 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: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: V94L55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention