MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC HD 1000I SHEARS 36CM SHAFT; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARHD36

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Insufficient Information (4580)

Event Date 11/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: how was the device used in the surgical procedure? no further information will be available.This complaint was reported during "" a retrospective study of the harmonic® 1000i shears in pediatric procedures."" the surgeon did not stayed in the hospital, so we cannot obtain the additional information.Was there a wound dehiscence? severe wound dehiscence occurred in (b)(6) 2020.No further information will be available.Were there any difficulties with the device that would have cause or contributed to the patient issue? there was no problem during the operation in (b)(6) 2020.No further information will be available.Can it be confirmed that there was post-op internal bleeding? no, it was just the result of blood test.There was no re-operation and map.If so, was the bleeding source identified and was it where the harhd36 was used? no further information will be available." 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 number was not provided.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.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 (b)(6) 2020, laparoscopic kasai operation on the biliary atresia was performed.The operation was completed without any problem.(b)(6) 2020, severe wound dehiscence occurred.Surgical procedure was performed.(b)(6) 2020, the patient fully recovered and was discharged from the hospital.(b)(6) 2020, the blood test was performed, and the amount of hemoglobin was 10.6g/dl.The patient was 0 - 12years old.The surgeon commented that it is unknown if the product is related to the issue.The blade tip was not broken off and no pieces fell into the patient.No further information is available.

• Brand Name: HARMONIC HD 1000I SHEARS 36CM SHAFT
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• 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: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13801328
• MDR Text Key: 288199970
• Report Number: 3005075853-2022-01610
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036015055
• UDI-Public: 10705036015055
• Combination Product (y/n): N
• PMA/PMN Number: K160752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARHD36
• Device Catalogue Number: HARHD36
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2022
• 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
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention
• Patient Sex: Female