ETHICON HARMONIC SCALPEL HAR36

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-29 for ETHICON HARMONIC SCALPEL HAR36 manufactured by Ethicon Endo Surgery.

Event Text Entries

[21875356] During a laparoscopic supracervical hysterectomy, after approx 3-5 mins of using the harmonic ace laparoscopic shears (cat # har36, lot # k92n77), the generator (serial # (b)(4)) alarmed to reactivate tips and quit working. Instrument was reactivated with same grey cord (serial # (b)(4)) and failed again. This was done twice with a new generator also with same results. Same lot number on shears. Used a different product to work on pt. No pt harm.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5035911
• MDR Report Key: 3793017
• Date Received: 2014-04-29
• Date of Report: 2014-04-29
• Date of Event: 2014-03-31
• Date Added to Maude: 2014-05-07
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ETHICON HARMONIC SCALPEL
• Generic Name: ACE LAPAROSCOPIC SHEARS
• Product Code: LFL
• Date Received: 2014-04-29
• Returned To Mfg: 2014-04-29
• Model Number: HAR36
• Lot Number: K92N77
• Device Expiration Date: 2018-10-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ETHICON ENDO SURGERY
• Manufacturer Address: GUAYNABO PR 00969 US 00969

Device Sequence Number: 2

• Brand Name: GENERATOR
• Generic Name: GENERATOR
• Product Code: GEI
• Date Received: 2014-04-29
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 2
• Device Event Key: 0

Device Sequence Number: 3

• Brand Name: CORD
• Generic Name: CORD
• Product Code: PDG
• Date Received: 2014-04-29
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 3
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-04-29