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

Catalog Number HARHD36

Device Problems Loose or Intermittent Connection (1371); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p94g4m.Investigation summary: the analysis results found that the device was received with the tissue pad detached and not returned and had evidence of body fluids and tissue pad material in the groove section of the clamp arm.The device was connected to a gen11 and the device did activate during functional testing.In addition, during functional testing, the device was activated for about 1 minute with no abnormal heat observed.The device was disassembled to inspect the internal components and no anomalies were found.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Based on the condition of the tissue pad, a probable cause of this damage is that the clamp of the device may have been closed and the instrument activated without tissue present.Care should be taken not to apply 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 resulting damage contributes to the removal of the pad from the clamp arm.The cleaning of the pad, not in accordance with the ifu, can also result in removal of the pad during use.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during a partial colectomy procedure, there was an overheating of the clamp which loosened the teflon.There was a need for another clamp to complete the surgery.There was no patient consequence.

• 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: 8426312
• MDR Text Key: 139076029
• Report Number: 3005075853-2019-17323
• 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: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2019

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: 11/30/2022
• Device Catalogue Number: HARHD36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR