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

Catalog Number HP054

Device Problems Material Fragmentation (1261); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p94f40.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 during a sleeve gastrectomy procedure, at the beginning of the case when they were assembling the disposable device to the handpiece, they were unable to get it tightened.When they attempted to remove the disposable from the handpiece, the metal transducer of the handpiece broke apart into several pieces and the handpiece housing was visibly open.The threaded stud was not broken off.The case was completed with another disposable device and another handpiece of the same product code.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Investigation summary the device was received with the nose cone disassembled and the nose cone was cracked.No functional testing could be done due to the condition of the returned device.It is possible that the cracked nose cone caused the reported assembly/disassembly issues.The end cap was disassembled to inspect remaining components and the moisture indicator was found to be positive.A ¿positive moisture indicator¿ describes a condition where water enters the handpiece cavity during the steam sterilization process due to the damaged nose cone.Analysis was unable to determine the exact root cause that lead to the crack in the handpiece nosecone.It is probable that the ingress of moisture affected the 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.

• 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: 8139951
• MDR Text Key: 129622361
• Report Number: 3005075853-2018-14892
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

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: 12/10/2018
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 01/07/2019
• Patient Sequence Number: 1
• Treatment: GENERATOR AND DISPOSABLE DEVICE