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

Model Number HAR1136

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Necrosis (1971); Pleural Effusion (2010); Pneumothorax (2012)

Event Date 12/09/2022

Event Type  Injury  

Event Description

It was reported via clinical trial (b)(6) the patient, after an unknown procedure, experienced pleural effusion, pneumothorax and anastomotic necrosis.All the ae have a possible relationship with the device and a causal relationship with the study.The aes required in-patient hospitalization or prolonged hospitalization.For all the aes, a drain insertion was required.

Manufacturer Narrative

(b)(4).Batch #: w7013l.Additional information was requested and the following was obtained: ae 2 pleural effusion: please clarify why this event is possible related to the study device? heat on pleura.Please clarify why this event is causal related to study procedure? this occurred post op.Ae 3 pneumothorax: please clarify why this event is possible related to the study device? related to leak.Please clarify why this event is causal related to study procedure? this occurred post op.Ae 4 anastomotic necrosis: please clarify why this event is possible related to the study device? heat.Please clarify why this event is causal related to study procedure? this occurred post op.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 batch 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.

• Brand Name: HARMONIC 1100 SHEARS, 36CM
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16157508
• MDR Text Key: 307284422
• Report Number: 3005075853-2023-00319
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036026167
• UDI-Public: 10705036026167
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K200841
• 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: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2022
• 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 Age: 73 YR
• Patient Sex: Male