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

Model Number	HARH45R
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photographs were received and reveal a sterilmed reprocessed device, along with the tyvek lid and device label for the reported packaging.They also reveal two different angles of the tip of the device which include the broken blade.The photos of the distal tip of the device also reveals the presence of contaminants consistent with patient contact on the jaws, hinge and shaft of the device as well as the broken blade.Based on the provided evidence in the photographs, the account's complaint is confirmed.The exact circumstances surrounding the blade breakage in the field is unknown, however, the blade may have been fractured during improper use or handling in the field.Per the instructions for use (ifu) ¿blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at the distal end of the shaft.To prevent burn injury, remove any visible tissue buildup at the distal end of the shaft.¿ in addition, the ifu states ¿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.¿ as such the root cause for this broken blade is unknown.A manufacturing record evaluation was conducted for the reported lot in the photo, 2126573.No non-conformances were identified.The device has not yet been returned for analysis.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).
Event or Problem Description
It was reported that a patient underwent a laparoscopic myomectomy with a reprocessed harmonic ace+7 shears with advanced hemostasis and the jaw broke off and fell into patient.There was no difficulty noticed before the break and no specific procedural or patient circumstance that contributed to the break.The tip was retrieved.There was patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent a laparoscopic myomectomy with a reprocessed harmonic ace+7 shears with advanced hemostasis and the jaw broke off and fell into patient.The device was returned for analysis on 14-dec-2021.None of the original packaging materials, label or originally supplied torque wrench were returned.The device serial number is (b)(6) which links it to lot 2126573.There was no observed structural damage to the housing or shaft of the device.It was observed that the jaw hinge and the proximal area of the tissue pad was covered in eschar and dried biological contaminants, indicative of patient contact.The tissue pad appears in proper position, whole and intact.The metal blade was broken in twain.The detached piece was examined under magnification and there were observed scratches and gouging in spots on the detached piece.The broken edge was jagged and not smooth.This confirms the reported issue, however it was undetermined what may have caused this damage, though this is indicative of contact with some type of hard or metallic object during use.Per the instructions for use, reprocessed harmonic ace® +7 shears with ah: "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.¿ the device was plugged into generator g11 (gen11 - software version 2016-1.1, id# (b)(6)).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 device history record for lot 2126573 was reviewed, and the device passed all visual and functional criteria prior to being distributed to the customer.A manufacturing record evaluation was conducted as 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).

• Brand Name: HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS
• Common Device Name: 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13005801
• Report Number: 2134070-2021-00032
• Device Sequence Number: 5441179
• Product Code: NLQ
• UDI-Device Identifier: 10888551045278
• UDI-Public: 10888551045278
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K182272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: HARH45R
• Device Catalogue Number: HARH45R
• Device Lot Number: 2126573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown