MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS FOCUS 9CM PLUS ADAPTIVE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR9F

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 3/21/2024 d4 batch #: unknown additional information was requested and the following was obtained: first and second degree (some blisters), but over a small area.No treatment other than wound care, has now healed without scarring and no long term harm done.Patient was informed, but in the context of the larger operation she was not overly concerned.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation is pending for the finished device lot number.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 at the end an unknown procedure it was apparent that the handpiece had caused a sustained superficial burn to the patient.The angle of the shear had meant that the section of the shear just before the working tip had made contact with the skin.The surgeon said that the device seemed sluggish, and didn't seem to cut as efficiently as it usually would.Patient reported to be doing well post operatively.

Manufacturer Narrative

(b)(4).Date sent: 4/10/2024.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• Brand Name: HS FOCUS 9CM PLUS ADAPTIVE
• 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: 18949133
• MDR Text Key: 338232740
• Report Number: 3005075853-2024-02298
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014669
• UDI-Public: 10705036014669
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HAR9F
• Device Lot Number: 646C76
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• 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 AND HANDPIECE
• Patient Outcome(s): Other