MAUDE Adverse Event Report: STERILMED, INC. HARMONIC SCALPELS/SHEARS; ELECTROSURG, CUT/COAG ACCESS, LAPAROSCOPIC & ENDOSCOPIC

Model Number	HAR36R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 or Problem Description
It was reported that a patient underwent a total laparoscopic hysterectomy with a reprocessed harmonic scalpels/shears and during colpotomy creation when the blade came in contact with the uterine manipulator the active blade broke.Broken piece was recovered without additional assistance.There was no difficulty noticed before the break.Another reprocessed device was used to complete the procedure.There were no adverse consequences for the patient.This event has been assessed as not mdr reportable.

• Brand Name: HARMONIC SCALPELS/SHEARS
• Common Device Name: ELECTROSURG, CUT/COAG ACCESS, LAPAROSCOPIC & ENDOSCOPIC
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 12523518
• Report Number: 2134070-2021-00021
• Device Sequence Number: 5337778
• Product Code: NUJ
• UDI-Device Identifier: 10888551045117
• UDI-Public: 10888551045117
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K161086
• 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
• Report Date (Section B): 09/02/2021

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 Model Number: HAR36R
• Device Catalogue Number: HAR36R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1