MAUDE Adverse Event Report: STERILMED, INC. HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS; SCALPEL, ULTRASONIC, REPROCESSED

Model Number HARH36R

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a laparoscopy procedure with a harmonic ace+7 shears with advanced hemostasis and a detachment in the patient issue occurred.During the procedure, the white insulated piece came off and the ultrasonic jaw piece was glowing.There was no patient harm, but the piece that broke off had to be retrieved using another laparoscopic instrument.The reusable cord was sent to sterile processing for testing and it was working correctly.No patient injury or consequence.Additional information received.The tip was glowing hot and the white piece came off.No specific procedural or patient circumstance that contributed to the failure.The ultrasonic jaw piece was glowing orange hot.The detachment in the patient was assessed as mdr reportable.The tip glowing issue was assessed as not mdr reportable for a damaged-jaw issue.

Manufacturer Narrative

The sterilmed product analysis lab received the device for evaluation on (b)(6) 2023.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by sterilmed, inc, or its employees that the report constitutes an admission that the product, sterilmed, inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a laparoscopy procedure with a harmonic ace+7 shears with advanced hemostasis and a detachment in the patient issue occurred.During the procedure, the white insulated piece came off and the ultrasonic jaw piece was glowing.There was no patient harm, but the piece that broke off had to be retrieved using another laparoscopic instrument.The reusable cord was sent to sterile processing for testing and it was working correctly.No patient injury or consequence.Additional information received.The tip was glowing hot and the white piece came off.No specific procedural or patient circumstance that contributed to the failure.The ultrasonic jaw piece was glowing orange hot.The device evaluation was completed on (b)(6) 2023.The device was returned in a resealable, biohazard plastic bag.None of the original packaging, labels, or supplied torque wrench were returned along with the device.The returned device was received with observed biological contaminants on the handle, shaft and tip of the device, eschar on the metal rod and melted remnants of the tissue pad.The top half of the tissue pad is not present, though it is noted to have been retrieved in the original report, with the base still seated within the jaw¿s groove with the edges appearing smooth and melted.The observations are indicative of continuous device activation without tissue present between the tissue pad and the metal rod.Continuous activation against the metal base of the tissue pad could have caused the metal to super heat and have a glowing, hot appearance.The reported issue is confirmed.The device was then attached to an ethicon harmonic hp054 hand piece and was secured with a torque wrench.It was plugged into generator g11 (gen11 - software version 2016-1.1) to verify functionality.The generator noted it was identifying the device, then proceeded to display the message "no instrument uses remaining".This indicates the device was operational, completed firing and sealing activities and had reached its end of life functionality.Per the instructions for use reprocessed harmonic ace® +7 shears with ah smi-420-543 rev.B, ¿blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at the distal end of the shaft.¿ it also notes ¿care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument." and, "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 and increased blade, clamp arm and distal shaft temperatures.¿ it notes in the operation of the device ¿for optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal end of the shaft throughout the procedure by activating the instrument tip in saline.¿ while the observed evidence is indicative of the device being actuated within the operative field without tissue between the blade and tissue pad, and the failure is reported to have occurred intra-op (with no clear indications that the warnings and instructions were followed), no specific conclusion as to the root cause for the reported issue is determined.The device history record (dhr) for lot 2136661 is reviewed and the device (s/n(b)(6)) is shown to have passed all visual and functional criteria prior to being distributed to the customer.An mre was conducted and there were no identified internal actions.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4).

• Brand Name: HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16281434
• MDR Text Key: 308842673
• Report Number: 2134070-2023-00005
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 10888551045247
• UDI-Public: 10888551045247
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARH36R
• Device Catalogue Number: HARH36R
• Device Lot Number: 2136661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1