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

Model Number MCM30

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

Patient Problems Adult Respiratory Distress Syndrome (1696); Cardiac Arrest (1762); Dyspnea (1816); Hematoma (1884); Hemorrhage/Bleeding (1888); Swelling/ Edema (4577)

Event Date 10/17/2021

Event Type  Death  

Event Description

It was reported that several hours post-op to a left hemi-thyroidectomy procedure, the patient developed a hematoma and ems brought the patient to the er.En route, the patient had been declared brain dead.During the initial procedure, the surgeon placed three clips on the artery and all appeared fine.Two hours post-op, the patient was scanned, discharged from the hospital, and sent home.Upon return to the hospital, the attending surgeon reopened the patient and noted that there were no clips on the artery and it appeared as though it had been sheared clean.The patient succumbed.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was received: 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.An analysis of the product could not be performed since a physical sample was not received for evaluation.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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.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: 2/28/2022 h11=corrected data=b2; h6 b2.Is hospitalization initial/prolonged: yes h6: health effect - clinical code: is dyspnea (e0717), not respiratory distress.

Manufacturer Narrative

(b)(4), date sent: 2/28/2022.H2: additional information received: received maude event report # mw5106257 with the following new information: the patient was a female with a past medical history of thyroid mass, during the procedure a total of 5 ligating clips were placed on the superior thyroid artery.1 medium clip and 2 small clips on one side that intentionally remained in the wound 2 clips on one side that were intentionally removed.All other vessels were double clipped.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.She was discharged home.The same day following an appropriate recovery.Several hours later.While home she experienced rapid neck swelling and shortness of breath.During transport by ems, the patient experienced cardiac arrest.The patient was returned to the operating facility.She was emergently taken to the operating room for neck exploration.The main bleeding source was found to be the superior thyroid artery.She remained in critical condition following this procedure and care was withdrawn in 2021.H11=corrected data=b3; h6.B3: 3.Date of event is now reported as (b)(6) 2021 (per ai in maude report received).H6: type of investigation is now device not returned (b17) (per ai in maude report received).

• 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: 12840904
• MDR Text Key: 280997466
• Report Number: 3005075853-2021-07046
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002482
• UDI-Public: 10705036002482
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2022

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: MCM30
• Device Catalogue Number: MCM30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 01/31/2022; 01/31/2022
• Supplement Dates FDA Received: 02/28/2022; 02/28/2022
• 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): Death; Required Intervention; Hospitalization
• Patient Sex: Female