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 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 02-nov-2022.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).

Event Description

It was reported that a patient underwent a hysterectomy procedure with a harmonic ace+7 shears with advanced hemostasis and a blade break in patient issue occurred.During the culpotomy, the device hit the uterine manipulator at which time the blade bent.Upon removal from the patient, the blade broke off completely.Broken piece of the blade was recovered.Another like device was used to complete the procedure.There were no adverse consequences for the patient.One device with the broken blade taped to the package will be returned.Additional information was received.The blade was not stuck in the patient.Did not require another device to remove nor did it require surgical intervention.There was no difficulty noticed before the break.There was no specific procedural or patient circumstance that contributed to the break.The issue was assessed as mdr reportable for a blade break in patient issue.

Manufacturer Narrative

The investigation was completed on 01-dec-2022.It was reported that a patient underwent a hysterectomy procedure with a harmonic ace+7 shears with advanced hemostasis and a blade break in patient issue occurred.During the culpotomy, the device hit the uterine manipulator at which time the blade bent.Upon removal from the patient, the blade broke off completely.Broken piece of the blade was recovered.Another like device was used to complete the procedure.There were no adverse consequences for the patient.The returned device was examined.The device serial number is (b)(6) which links it to lot 2127434.There is no observed structural damage to the housing or shaft of the device.It is observed that the jaw, the hinge, the tissue pad and the cutting rod are covered in eschar and dried biological contaminants; indicative of exposure within the operative field and patient contact.The tissue pad appears in proper position, whole and intact.The metal blade is broken in twain.The detached piece was examined under magnification.There is an observed gouge near the breakage spot on the detached piece.The broken edge is jagged and not smooth.This confirms the reported issue.The appearance of this damage is indicative of contact with other metal during use, as is noted in the report that the device made contact with the metal section of a uterine manipulator (a surgical instrument).Per the instructions for use, reprocessed harmonic ace® +7 shears with ah smi-420-543 rev.B: "avoid contact with any and all metal or plastic instruments or objects when the instrument is activated.Contact with staples, clips, or other instruments while the instrument is activated may result in cracked or broken blades." and "caution: scratches on the blade may lead to premature blade failure.- avoid accidental contact with other instruments during use.It was plugged into generator g11 (gen11 - software version 2016-1.1, id# 1111449075).The generator noted it was identifying the device, but then displayed the message "no instrument uses remaining".The device was disconnected and re-attached and it resulted in the same display.Device has been used and has reached its end of life.The account did not note any generator errors.The dhr for lot 2127434 was reviewed and the device passed all visual and functional criteria prior to being distributed to the customer.An mre was conducted as 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: 15744335
• MDR Text Key: 303169246
• Report Number: 2134070-2022-00022
• 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: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• 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: 2127434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS