MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC LAP 5MM SHEAR 36CM; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HAR36

Device Problem Failure to Deliver Energy (1211)

Patient Problem Blood Loss (2597)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: r9490r.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.Following information has been requested.To date response has not been received: on what anatomical structure was the device fired in the initial procedure? were any generator alert screens seen during the procedure? what was the power level? what was the approximate width of the vessel? what is the surgeon¿s experience with harmonic technology? were there any generator alert screens? was there an additional surgical procedure? what was the site of the bleeding? was this an area where the harmonic device was used?.

Event Description

It was reported that during an unknown procedure, har36 does not perform vessel sealing (coagulation) during cutting and coagulation.There was no information about the blood loss however it was learned there was blood returned to the patient during surgery.No other details provided.

Manufacturer Narrative

(b)(4).Date sent: 9/18/2020.Different conclusion codes used in investigation than what was originally reported: correction medwatch.H10: corrected data = h6.

Manufacturer Narrative

(b)(4).Date sent: 9/11/2020.Investigation summary: the device was returned with no apparent damage.The device was connected to a test hand piece and tested on a gen11.The device was functional and worked as intended.The device was tested with the test media and performed as expected, no anomalies were noted.There were no anomalies noted with the functionality of the device.During analysis, it was determined that the device was connected to more than one generator.Adaptive tissue technology devices are supplied sterile, single patient use instruments.Using the device on more than one generator is potentially associated with device re-use.Multiple patient use may compromise the device integrity or create a risk of contamination that, may result in patient injury or illness.If the device is connected to a different generator an alert screen will be displayed indicating ¿adaptive tissue technology features are not available in this device¿.The device was disassembled to inspect the internal components and no anomalies were noted.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.This device is packaged and sterilized for single use only.Multiple patient use may compromise the device integrity or create a risk of contamination that, in turn, may result in patient injury or illness.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: HARMONIC LAP 5MM SHEAR 36CM
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9842150
• MDR Text Key: 191261619
• Report Number: 3005075853-2020-01656
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014447
• UDI-Public: 10705036014447
• Combination Product (y/n): N
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• Device Lot Number: R9490R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Date Manufacturer Received: 09/03/2020
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE
• Patient Outcome(s): Required Intervention