MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC 1100 SHEARS, 36CM; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HAR1136

Device Problem Failure to Read Input Signal (1581)

Patient Problems Necrosis (1971); Insufficient Information (4580)

Event Date 09/23/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: what was the original procedure? esophagectomy with primary indication for esophageal cancer.Where was the device used during the procedure? per email from site, "the entire procedure".Were there any device malfunction/deficiency during the original procedure? per email from the site, "no".Were there any user handling issues with the device during the original procedure? per email from the site, "no".Can the pi clarify why he considers this event to be possibly related to the study device? possible heat from harmonic.When was the necrosis identified in relation to the completion of the original procedure? (b)(6) 2022, during a post-operative gastrocopy.What is the patient¿s current status? the patient is still hospitalized.A follow-up gastrocopy (b)(6) 2022 and a barrium swallow (b)(6) 2022 showed the esophageal stent in place and absence of esophageal leak.Another barrium swallow will be done today.The patient was discharged ((b)(6) 2022).An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

Event Description

It was reported that during an unknown procedure for clinical trial (b)(6) the patient experienced esophageal anastomotic necrosis.The patient required in-patient hospitalization or prolongation of existing hospitalization.The patient required stent insertion twice and iv antibiotherapy.The event is possibly related to the device and probably related to the study procedure.

Manufacturer Narrative

(b)(4).Date sent: 11/22/2022.Additional information was obtained: specify value "stent insertion x2" has been changed to "stent insertion x2.Stent removal" outcome value "not recovered/not resolved" has been changed to "recovered/resolved without sequelae".

Manufacturer Narrative

(b)(4).Date sent: 4/3/2024.Additional information was obtained: drug therapy was used to address the adverse event.

• Brand Name: HARMONIC 1100 SHEARS, 36CM
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 15682613
• MDR Text Key: 302510887
• Report Number: 3005075853-2022-07322
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036026167
• UDI-Public: 10705036026167
• Combination Product (y/n): N
• PMA/PMN Number: K200841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAR1136
• Device Catalogue Number: HAR1136
• Device Lot Number: W7013L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male