MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. .; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR9F

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot/batch.

Event Description

It was reported that during a breast procedure, the active blade started to bend and then broke off.No error messages were displayed.Case completed with another device of the same product code.There were no patient consequences reported.The device and broken blade were discarded.

• Brand Name: .
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5261024
• MDR Text Key: 32710494
• Report Number: 3005075853-2015-07706
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HAR9F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1