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

Catalog Number HPBLUE

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: r9434l.Investigation summary: the device was received with no apparent damage.The handpiece was assembled and disassembled to a test instrument without any difficulty.Then, the handpiece was connected to a gen11 and was found to be functional.The instrument was disassembled to inspect the internal components.The moisture indicator was positive.The handpiece has a number of seals to prevent fluids from entering the housing."positive moisture indicator¿ describes a condition where water enters the handpiece cavity during the steam sterilization process.The primary path of ingress is the distal seal, this may be caused by a reduction of the compressive force on the distal seal.However no definitive root cause could be drawn.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.It is probable that the ingress of moisture affected handpiece functionality.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

Event Description

It was reported that during an unknown procedure the device had a tightening issue.No patient consequence or delay reported.

• Brand Name: HARMONIC BLUE HAND PIECE
• Type of Device: ULTRASONIC SURGICAL SYSTEM HANDPIECE, HAND-CONTROLLED, REUSABLE
• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10817229
• MDR Text Key: 215614793
• Report Number: 3005075853-2020-05878
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036002154
• UDI-Public: 10705036002154
• Combination Product (y/n): N
• PMA/PMN Number: K063192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GENERATOR.