MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC LAP 5MM SHEAR 36CM; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR36

Device Problem Failure to Shut Off (2939)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The lot history records were reviewed, and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that during an unknown procedure, the scissors did not switch off.Patient consequence was not reported.

Manufacturer Narrative

(b)(4).The patient did not experience any patient consequence.

• Brand Name: HARMONIC LAP 5MM SHEAR 36CM
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7766122
• MDR Text Key: 116801863
• Report Number: 3005075853-2018-11933
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036014444
• UDI-Public: 20705036014444
• Combination Product (y/n): N
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: HAR36
• Device Lot Number: P94D9K
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2018
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE