MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. EES GENERATOR; INSTRUMENT, ULTRASONIC SURGIICAL

Catalog Number GEN11

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Burn(s) (1757); Insufficient Information (4580)

Event Date 11/16/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: not applicable.Additional information was requested and the following was obtained: please provide generator serial number to add to the case file.Unknown.Has the generator been serviced? when it was services last? unknown.Is the generator faulty? no.Does the generator being returned ? no.Please provide lot number of the har9f unknown.What is the surgeon's experience with device? very experienced.Uses it regularly for 5+ years.How long into procedure was the issue identified? the device was working fine for the majority of the procedure.It was noticed when the second tone was not heard.The device was not sensing tissue had been sealed so charring occurred.Were there any unusual noises heard from device? no.Just excessive time on ¿first tone¿.Were there any generator alert screens throughout procedure? no.Is a generator log available for review? no.What proactive heat management techniques were utilized during the procedure by surgeon and staff? unknown what was the anatomical location of the thermal injury/charred tissue? beside the parotid gland.What was the degree of burn/thermal damage? charred tissue.Is a photo of the thermal injury available? no.Was the patient's post-operative care altered in any way as a result of the issues.Experienced during the procedure? no.What is the patient's current status? no adverse effects.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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 a parotidectomy the tissue pad slipped off.There was some thermal injury/damage to surrounding tissue which had to be removed.Gen11 did not recognize there was a problem with the device.The tone of the generator never went to the secondary tone and it was at this stage the surgeon realized there was a problem.The procedure was delayed 10 minutes to remove the additional charred tissue and replace the device.The procedure was completed successfully with no significant clinical outcome.

• Brand Name: EES GENERATOR
• Type of Device: INSTRUMENT, ULTRASONIC SURGIICAL
• 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: 16004182
• MDR Text Key: 305703691
• Report Number: 3005075853-2022-08741
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GEN11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention