MAUDE Adverse Event Report: ETHICON ENDO-SURGERY HARMONIC SCALPEL

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2018

Event Type  No Answer Provided  

Event Description

Harmonic scalpel used during case per surgeon's preference/routine.White teflon liner of the instrument tip became detached during use while inside the patient's abdomen.Tip immediately retrieved (one intact piece) by surgeon.Second handpiece opened, white liner became loose (but did not detach) while in use by surgeon.

• Brand Name: HARMONIC SCALPEL
• Type of Device: HARMONIC SCALPEL
• Manufacturer (Section D): ETHICON ENDO-SURGERY; 475 calle c; guaynabo PR 00969
• MDR Report Key: 7536866
• MDR Text Key: 109131181
• Report Number: MW5077403
• Device Sequence Number: 2
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/07/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR