MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC HD 1000I SHEARS 36CM SHAFT; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARHD36

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.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 the use of the device, the tissue pad began to release.Some of the procedure was done and the device did not work properly anymore.The surgeon did not want to open another device because the surgery was at the end.It did not hurt the patient.

Manufacturer Narrative

(b)(4).Batch # r93c6m.Investigation summary: the device was returned with the tissue pad damaged, melted not all present and a portion was not returned.In addition, the tissue pad was attached to the clamp arm and not detached as reported by the customer.The device was connected to a gen11 and the device did activate during functional testing.The device was disassembled to inspect the internal components and no anomalies were found.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between them.Keep the clamp arm open when back-cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Manufacturer Narrative

(b)(4).There was no damage to the patient.It was not an adverse event, however the tweezers detached the teflon part when it was in normal use.After the teflon detached, the device did not work properly anymore.

• Brand Name: HARMONIC HD 1000I SHEARS 36CM SHAFT
• 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: 8117907
• MDR Text Key: 129051317
• Report Number: 3005075853-2018-14668
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036015055
• UDI-Public: 10705036015055
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K160752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2018

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 Expiration Date: 04/30/2023
• Device Catalogue Number: HARHD36
• Device Lot Number: R93M4N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 11/21/2018; 11/21/2018
• Supplement Dates FDA Received: 11/29/2018; 01/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Sex: Female