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

Model Number ER420

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

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2023

Event Type  Injury  

Event Description

It was reported that during a laparoscopic nissen fundoplication, the er420 was used to ligate a short gastric vessel.The first clip scissored and ruptured the short gastric vessel.Subsequent clips were scissored and prevented the surgeon from controlling the bleeding from the short gastric.The volume and rate of bleeding dictated opening the patient with a laparotomy which delayed procedure by 30 minutes.The surgeon successfully controlled the bleeding after opening the patient using other means of ligation, pressure and hemostatic agents.Procedure was successfully completed.There were no fragments generated.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 7/12/2023.D4: batch # unk.Additional information was requested and the following was obtained: "what is surgeons experience with this device? decades with er320, new to er420 were there any complications during the initial procedure? this was the initial procedure.There were no other complications besides this was the surgeon able to visualize a clip fed into the jaws prior to firing the device? the surgeon customarily confirms the presence of a clip when using er320, and er420 is no different.He does not have a specific recollection of confirming a clip in this case.He is confident that there was a clip since the complication occurred after firing the first clip were there any feeding issues experienced with the device? none noted.Was there any excessive torquing of the device at the time of firing? none noted how much bleeding occurred? dr did not provide an estimate in cc's.It was uncontrolled and obscured the entire field of vision.Were any blood products given? no.If so, how much? stated that, "the first clip scissored and ruptured the short gastric vessel".Was this the very first clip fired from the device? yes.What is the current patient status? patient was discharged post op day 4." an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17305389
• MDR Text Key: 318923735
• Report Number: 3005075853-2023-04857
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/12/2023
• 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