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

Model Number MCS20

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

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Hematoma (1884); Hemorrhage/Bleeding (1888); Swelling/ Edema (4577)

Event Date 10/17/2021

Event Type  Death  

Manufacturer Narrative

(b)(4).Batch # unk.Initial reporter first name/last name: is unknown as was reported as confidential on maude event report # mw5106257.Maude event report # is mw5106257.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.An analysis of the product could not be performed since a physical sample was not received for evaluation.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 (sales rep reached out to hospital staff): what was the indication for initial surgical procedure? left hemi-thyroidectomy did the patient have any pre-existing conditions that would have caused or contributed to the event? asked but not answered.Any difficulty with clip application in primary surgical procedure? no complication.How many clips were placed on the patient side? 3.How many clips were placed on the specimen side? not answered.Are there any photos or scans available for review? asked but not answered.What is the surgeon¿s experience with the device? very high.Has been using the clip appliers for many years.Is there an autopsy report available? asked but not answered.Is the surgeon interested in speaking with ethicon medical and engineering staff? asked but not answered.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

The patient with a past medical history of thyroid mass underwent a left hemi thyroidectomy.During the procedure, a total of 5 ligating clips were placed on the superior thyroid artery (three clips, two of which were small clips, were placed on one side that intentionally remained in the wound, and two clips on one side that were intentionally removed).All other vessels were double clipped with no extra bleeding noted following induced valsalva maneuvers.Before surgical closure, the incision was irrigated, dried with a sponge, and noted to be dry.The incision was closed and the patient was moved to recovery.Two hours post-op, patient was scanned, was discharged from the hospital, and sent home the same day following an appropriate recovery.Several hours later, while home, patient experienced rapid neck swelling and shortness of breath.The patient developed a hematoma and ems brought patient to er.During transport by ems, the patient experienced cardiac arrest and had been declared "brain dead." the patient was returned to the operating facility and patient was emergently taken to the operating room for neck exploration.The attending surgeon reopened the patient and noted there were no clips on the artery an it appeared as though it had been sheared clean.The main bleeding source was found to be the superior thyroid artery.Patient remained in critical condition following this procedure and care was withdrawn in 2021.The patient succumbed.

• 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 ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13625922
• MDR Text Key: 286315891
• Report Number: 3005075853-2022-01204
• 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: Other,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCS20
• Device Catalogue Number: MCS20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2022
• 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): Hospitalization; Death; Required Intervention
• Patient Sex: Female