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

Catalog Number HP054

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p93u98.The batch history records were reviewed and the manufacturing criteria were met prior to the release of this batch.

Event Description

It was reported that black-brown colored liquid was leaking from the housing of the hand piece at the first sterilization.The hand piece was wiped and the sterilization was performed again but the same event continued.The number of the remaining uses of hp054 was 95.The hand piece was not used for the patient.Another hand piece was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Device analysis: the device was received with no apparent damage.The handpiece was connected to a test device and tested on a gen11.The device was functional and worked as intended.There were no anomalies noted with the functionality of the handpiece.The instrument was disassembled to inspect the internal components and no anomalies were found as 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
• MDR Report Key: 7359966
• MDR Text Key: 103267182
• Report Number: 3005075853-2018-08696
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036002144
• UDI-Public: 20705036002144
• Combination Product (y/n): N
• PMA/PMN Number: K002906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• 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: 04/18/2018
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1