MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC LAPAROSCOPIC HARMONIC AVE +7 SHEARS; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number P30223P24

Device Problems Electrical /Electronic Property Problem (1198); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

Laparoscopic harmonic ace + 7 shears not registering in the middle of a laparoscopic sigmoid colectomy.Fda safety report id# (b)(4).

• Brand Name: LAPAROSCOPIC HARMONIC AVE +7 SHEARS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; guaynabo PR 00969
• MDR Report Key: 14934351
• MDR Text Key: 295476774
• Report Number: MW5110679
• Device Sequence Number: 1
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P30223P24
• Device Lot Number: W70018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male