MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC FOCUS 500 SHEARS; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number FCS509CN

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: w7006u.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.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 thyroid procedure, before using it on the patient, it was found that the product lacked label about the product.Changed to a new device to complete the surgery.There was no patient consequence reported.No additional information can be provided.

Manufacturer Narrative

(b)(4).Date sent: 12/1/2022 investigation summary the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the fcs509cn device was returned sealed inside its original packaging with no apparent damage.During a visual inspection, no abnormalities are observed in the identification of the returned sample.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.As part of ethicon endo-surgery quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: HARMONIC FOCUS 500 SHEARS
• 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: 15710707
• MDR Text Key: 307177207
• Report Number: 3005075853-2022-07479
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FCS509CN
• Device Lot Number: 742A99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE