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

Catalog Number HAR1136

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 12/29/2023

Event Type  Injury  

Event Description

It was reported that during an unknown procedure the shears, utilized for the salpingectomy, heated up along the shaft of the instrument causing a thermal burn of the patient's small bowel.When the shaft was lifted off the bowel, it had adhered to the bowel, approx 3-5 cm up the shaft of the shears.It was evident that the shaft was hot.The issue was discovered quickly.Due to the instrument shaft being adhered when the instrument was lifted away from the bowel, the tip of the instrument ("jaws") touched the bowel, causing another burn.It was noted that when the device was initially utilized it was not cutting or cauterizing as expected.Instrument and generator were removed from operation room and taken to biomed to be inspected and sequestered.

Manufacturer Narrative

(b)(4).Date sent: 2/23/2024.D4 batch #: x70329.Mdr# mw5150073.Additional information was received: we did find out it¿s a gyn surgeon with harmonic experience.A general surgeon was called to the room and determined the burn was full thickness and would require a bowel resection.There are no intraoperative photos.Biomed inspected the generator and device.He could not replicate the incident.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.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.

Manufacturer Narrative

(b)(4) date sent: 4/9/2024 d4 batch #: x70329 additional information was obtained: there was a patient who was undergoing a tubal ligation and bilateral salpingectomy.When the harmonic was starting to be used, it was not cutting/coag as expected.So, the surgeon chose to withdrawal the device.This is when it was discovered the shaft was adhered to the bowel (about an inch or 2 up from the jaws).When the device was removed, there was a thermal injury to the bowel.They were able to maintain visual of the injury and had a general surgeon come in and do a small resection of the bowel.Investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the device was returned with no apparent damage.The compliant device was plugged into a gen11 generator and activated using both the energy button and advance hemostasis button on wet chamois.The device worked as intended and cut normally, no unusual heat or any other issues/anomalies were observed.While activating the device, the entire length of the shaft of the device was held and no hot spots were identified.The gen11 generator log was reviewed with the following findings: from the device eeprom device plugged into generator 1111125562 a total of 6 times ¿ confirmed through generator log review.Device saw a total of 15 activations ¿ confirmed through generator log review.In summary, it appears that the second activation during the complaint procedure experienced an extended advanced hemostasis activation with 7 seconds of att time (active time on the tissue pad with the jaws closed with limited or no tissue present).During an extended activation the blade temperature can be expected to rise.Per the device ifu: during and following activation in tissue, the instrument blade, clamp arm, and distal 7 cm of the shaft may be hot.Avoid unintended contact with tissue, drapes, surgical gowns, at all times.Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number x70329, and no non-conformances were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.

Manufacturer Narrative

(b)(4).Date sent: 3/13/2024.

• 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: 18770742
• MDR Text Key: 336136003
• Report Number: 3005075853-2024-01591
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HAR1136
• Device Lot Number: X70329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention