MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC HD 1000I SHEARS 20CM SHAFT; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARHD20

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that the harmonic device where the blades have shattered during surgery.No patient consequence reported.

Manufacturer Narrative

(b)(4).Date sent: 1/13/2020.H10: corrected data = d1 and d4.Additional information was requested and the following was obtained: what is the product code for this complaint? harhd20.What efforts were made to locate the broken blade tip during the procedure? cavity inspection and wash out.Was this procedure converted to an open procedure? this was an open procedure.Are there any plans to locate the piece? attempted during procedure however lots of ligaclips used and xray would not be useful finding small piece of metal because of this was there any change in the patient care as a result of this event? no.What is the current patient status? i have requested this from surgeon but no response as yet.

• Brand Name: HARMONIC HD 1000I SHEARS 20CM SHAFT
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9513199
• MDR Text Key: 191858246
• Report Number: 3005075853-2019-24740
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K160752
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HARHD20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Patient Sequence Number: 1
• Treatment: HANDPIECE AND GENERATOR