MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ACE LAPAROSCOPIC SHEARS HARMONIC SCALPEL; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HAR36

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2020

Event Type  malfunction  

Event Description

During testing of the ace shears, following the passing of the initial test, the "min" button would not function.Fda safety report id # (b)(4).

• Brand Name: ACE LAPAROSCOPIC SHEARS HARMONIC SCALPEL
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; guaynabo PR 00969
• MDR Report Key: 10967323
• MDR Text Key: 220499848
• Report Number: MW5098247
• Device Sequence Number: 1
• Product Code: LFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• Device Lot Number: U94N5C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 65 YR