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

Model Number ER420

Device Problems Use of Device Problem (1670); Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/17/2021

Event Type  Injury  

Event Description

It was reported that after a laparoscopic distal gastrectomy, one day after the surgery, a code blue was called due to an unconscious critical condition.Massive bleeding occurred from the left gastroepiploic artery where a teardrop shaped clip was deployed.The amount of bleeding was unknown.No transfusion was required.A deployed clip on the left gastroepiploic vein almost came off as well.The procedure was converted to open, and an emergency surgery was performed.The patient is hospitalized in icu.No further information is available.

Manufacturer Narrative

(b)(4).Batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot/batch number was not provided.As part of our quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product or additional information is received at a later date, the investigation will be updated as applicable.Additional information received: no bleeding was observed during initial procedure.The surgeon commented that he did not grasp the trigger fully.The clip might be half formed.A harmonic was used to cut the artery.The patient left icu and moved to general ward.An encephalopathy was not observed.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: were there any difficulties with clip formation noted during the initial laparoscopic distal gastrectomy procedure? did surgeon inspect each clip after application during initial procedure? is lot number or batch number available for this er420 device? what is surgeon¿s experience with the er420 device? did surgeon fire plastic to plastic for each clip fired from the er420 device during the initial procedure? if reoperation occurred the day after initial procedure, how long after initial procedure was it before patient was reoperated? how was post op bleeding found or diagnosed? did reoperation begin as laparoscopic exploration? was the reoperation a laparoscopic exploration that was subsequently converted to an open procedure? what was found during reoperation? was the tear drop shaped clip found during reoperation (if so, where was it found)? what is meant by ¿a deployed clip on the left gastroepiploic vein almost came off as well (please clarify, was this clip not holding, or was this clip malformed, or please describe specifically if there was some other issue with this clip)?¿ what device or devices were used during the reoperation and how was bleeding controlled or resolved during reoperation (how was patient treated)? an unknown harmonic device was also mentioned in the additional information.What is product code for the harmonic device that was used in the initial procedure? what is the lot/batch number of the harmonic device that was used in the initial procedure? what artery was the harmonic device used on to coagulate? was that also the same artery that was clipped with the er420? if so, was the clip applied after the harmonic device was used? is surgeon alleging a deficiency with the harmonic device? was the harmonic device also discarded and unavailable for analysis? what is the current status of this patient? 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: 2/2/2022.H2: additional information received: attempts were made to obtain additional information and the following additional information was received: were there any difficulties with clip formation noted during the initial laparoscopic distal gastrectomy procedure? did surgeon inspect each clip after application during initial procedure? no bleeding occurred during initial procedure.Is lot number or batch number available for this er420 device? no information from the hospital.What is surgeon¿s experience with the er420 device? the hospital uses er420 and el5ml, the sales rep commented the information about the difference of two type of clip was not explained to this hospital enough.Did surgeon fire plastic to plastic for each clip fired from the er420 device during the initial procedure? no.Dr didn¿t fire plastic to plastic.Dr thought the fire was finished from only feeling of firing.If reoperation occurred the day after initial procedure, how long after initial procedure was it before patient was reoperated? no further information from the hospital.How was post op bleeding found or diagnosed? no further information from the hospital.Did reoperation begin as laparoscopic exploration? no.The reoperation was open procedure.Was the reoperation a laparoscopic exploration that was subsequently converted to an open procedure? no.What was found during reoperation? the clip for artery was formed half.The clip for vein was not formed properly.Was the tear drop shaped clip found during reoperation (if so, where was it found)? yes.What is meant by ¿a deployed clip on the left gastroepiploic vein almost came off as well (please clarify, was this clip not holding, or was this clip malformed, or please describe specifically if there was some other issue with this clip)?¿ this clip was malformed.What device or devices were used during the reoperation and how was bleeding controlled or resolved during reoperation (how was patient treated)? no further information from the hospital.An unknown harmonic device was also mentioned in the additional information.What is product code for the harmonic device that was used in the initial procedure? no further information from the hospital.What is the lot/batch number of the harmonic device that was used in the initial procedure? no further information from the hospital.What artery was the harmonic device used on to coagulate? no further information from the hospital.Was that also the same artery that was clipped with the er420? yes.After clipping, the same artery was dissected by harmonic.If so, was the clip applied after the harmonic device was used? no.After clipping, the same artery was dissected by harmonic.Is surgeon alleging a deficiency with the harmonic device? no.Was the harmonic device also discarded and unavailable for analysis? yes.What is the current status of this patient? the patient is stable.

• 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: 13019541
• MDR Text Key: 285166553
• Report Number: 3005075853-2021-07798
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization