MAUDE Adverse Event Report: ETHICON ENDO-SURGERY ACE LAPAROSCOPIC SHEARS; HARMONIC SCALPEL, 5MM X 36CM

Model Number HAR36

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 06/13/2014

Event Type  malfunction  

Event Description

An ethicon endo-surgery ace laparoscopic shears would not pass the initial generator test.Reason for use: laparoscopic assisted vaginal hysterectomy.

• Brand Name: ACE LAPAROSCOPIC SHEARS
• Type of Device: HARMONIC SCALPEL, 5MM X 36CM
• Manufacturer (Section D): ETHICON ENDO-SURGERY; guaynabo 00969
• MDR Report Key: 3893838
• MDR Text Key: 16546899
• Report Number: MW5036787
• 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: 06/17/2014

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 Expiration Date: 03/31/2019
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• Device Lot Number: L90Y9C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR