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 06/30/2021

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 laparoscopic hysterectomy procedure with a reprocessed harmonic ace+7 shears with advanced hemostasis and the blade broke off and fell in the patient.The blade was removed.There was no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event has been assessed as an mdr reportable event.

Manufacturer Narrative

It was reported that a patient underwent a laparoscopic hysterectomy procedure with a reprocessed harmonic ace+7 shears with advanced hemostasis and the blade broke off and fell in the patient.In the initial report, it was noted the device was returned.During investigation it was determined the device returned was not for this complaint.The device for this complaint was discarded.We could not confirm the reported issue because the product said to be involved was not received for evaluation.Since the device was not returned for evaluation, the visual and functional inspections could not be performed.A manufacturing record evaluation was conducted for the finished device lot 2122197 and no nonconformances were identified.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
• MDR Report Key: 12228123
• MDR Text Key: 263615053
• Report Number: 2134070-2021-00016
• 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
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: HARH36R
• Device Catalogue Number: HARH36R
• Device Lot Number: 2122197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1