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

Model Number HARH36R

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

The product analysis lab received the device for evaluation.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a reprocessed harmonic ace+7 shears with advanced hemostasis and the tissue pad fell off while in use.Tissue pad was recovered.The intent of the procedure was not altered as a result of this event and there was no patient consequence.

Manufacturer Narrative

It was reported that a patient underwent a procedure with a reprocessed harmonic ace+7 shears with advanced hemostasis and the tissue pad fell off while in use.Tissue pad was recovered.The device was returned in a sealed plastic biohazard bag, with none of the other original packaging or accessories provided.The returned device was received with observed biological contaminants on the handle, shaft and tip of the device, eschar on the metal rod and a missing tissue pad.While it was reported that the tissue pad was retrieved and is not in the patient, it was not returned with the device.The base of the tissue pad is still seated within the jaw¿s groove with the edges appearing smooth and melted, indicating the top, exposed portion of the tissue pad had melted to the base, allowing the remainder of the pad to detach.The observations are indicative of continuous device activation without tissue present between the tissue pad and the metal rod.The reported issue was confirmed.Per the failure modes and effects analysis (fmea) for harmonic ace with att, possible causes for the "pad missing or fragments fall off" is "damage to the distal tip," "activation of device without tissue between the blade and the pad," and physician misuse." per the instructions for use reprocessed harmonic ace® +7 shears, ¿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 backcutting 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.¿ the presence of biological contaminants, eschar on the metal rod, melting of the tissue pad and "no instrument uses remaining" display when presently plugged in, is also evidence that the device had been fully operational, completed firing and sealing activities.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 conclusion as to the cause for the reported issue can be determined.The device history record for lot 2149498 is reviewed and the device is shown to have passed all visual and functional criteria prior to being distributed to the customer.An manufacturing record evaluation was conducted and there were no identified non-conformances.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4) correction to initial report, as the lot number was omitted in error.D4 of this form has been updated to include lot# 2149498.

• 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
• MDR Report Key: 12175982
• MDR Text Key: 264760186
• Report Number: 2134070-2021-00012
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 10888551045247
• UDI-Public: 10888551045247
• Combination Product (y/n): N
• PMA/PMN Number: K182272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2023
• Device Model Number: HARH36R
• Device Catalogue Number: HARH36R
• Device Lot Number: 2149498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1