MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC BLUE HAND PIECE; ULTRASONIC SURGICAL SYSTEM HANDPIECE,

Catalog Number HPBLUE

Device Problems Fluid/Blood Leak (1250); Failure to Read Input Signal (1581)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: (b)(4).Batch # x94z6 only event year known: 2022 investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device serial number, and no [non-conformances / manufacturing irregularities] were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.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 an unknown procedure the device caused multiple errors.The sales rep reconnected the instrument to the handpiece and the procedure continued.The sales rep did notice an unknown residue on the handpiece after the procedure.No patient harm was reported.

• Brand Name: HARMONIC BLUE HAND PIECE
• Type of Device: ULTRASONIC SURGICAL SYSTEM HANDPIECE,
• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15448260
• MDR Text Key: 305415192
• Report Number: 3005075853-2022-06220
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036002154
• UDI-Public: 10705036002154
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HPBLUE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GENERATOR