MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL HAND PIECE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HP054

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # w90w1e.Investigation summary: the handpiece was received with the nose cone cracked.It was connected to a generator, evaluated with a test instrument and was found to be functional.The instrument was disassembled to inspect the internal components and the moisture indicator was positive.Due to the cracked nose cone, moisture entered the hand piece mid housing.Analysis was unable to determine the exact root cause that lead to crack in the hand piece nosecone.It is possible that the ingress of moisture affected handpiece functionality.The batch history record was reviewed, and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during a prostatectomy procedure, there was always the request to tighten the device.Even new scissors did not change that request.Then the test was no longer possible.No harm to the patient is reported.

• Brand Name: HARMONIC SCALPEL HAND PIECE
• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7986442
• MDR Text Key: 124987680
• Report Number: 3005075853-2018-13788
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036002147
• UDI-Public: 10705036002147
• Combination Product (y/n): N
• PMA/PMN Number: K002906
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HP054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2012
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1