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 04/12/2022

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 an unknown procedure with a reprocessed harmonic ace+7 shears with advanced hemostasis.The device was used off label on a metal uterine manipulator and the blade fractured and was unusable.There was no difficulty noticed prior to the break.Fragments were generated and removed easily without additional intervention.There was no reported patient consequence.

Manufacturer Narrative

It was reported that a patient underwent an unknown procedure with a reprocessed harmonic ace+7 shears with advanced hemostasis.The device was used off label on a metal uterine manipulator and the blade fractured and was unusable.The returned device was examined.The device serial number is (b)(6) which links it to lot 2131872.There is no observed structural damage to the housing or shaft of the device.It was observed that the jaw, the hinge, the tissue pad and the cutting rod were covered in eschar and dried biological contaminants; indicative of patient contact and multiple sealings.The tissue pad appears in proper position, whole and intact.The metal blade was broken in twain.The detached piece was examined under magnification.There are observed scratches and gouging in spots on the detached piece.The broken edge was 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 from the account that the device improperly made contact with the metal section of a uterine manipulator (a surgical instrument) during the procedure, resulting in a broken blade.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.¿ it was plugged into generator g11.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 device history record for lot 2131872 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 nonconformances.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
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14311639
• MDR Text Key: 290962652
• Report Number: 2134070-2022-00010
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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