MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE PLUS 7 W ADV HEMOSTASIS; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARH36

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that during a lap colon procedure, the pad came loose from device.Case completed with another device of the same product code.There were no patient consequences reported.

• Brand Name: HARMONIC ACE PLUS 7 W ADV HEMOSTASIS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7978053
• MDR Text Key: 124348069
• Report Number: 3005075853-2018-13691
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014621
• UDI-Public: 10705036014621
• Combination Product (y/n): N
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2018

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 Catalogue Number: HARH36
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1