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

Model Number	HAR36R
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a hysterectomy with a reprocessed harmonic scalpels/shears and the device was not coagulating correctly.The surgeon felt like the device was not performing as intended regarding hemostasis.Another like device was used to complete the procedure.There was no damage observed on the device.Surgery was not delayed due to the event.There was no patient consequence.The patient did not require extended hospitalization because of the event.
Event or Problem Description
It was reported that a patient underwent a hysterectomy with a reprocessed harmonic scalpels/shears and the device was not coagulating correctly.The surgeon felt like the device was not performing as intended regarding hemostasis.Another like device was used to complete the procedure.There was no damage observed on the device.Surgery was not delayed due to the event.There was no patient consequence.The patient did not require extended hospitalization because of the event.
Additional Manufacturer Narrative
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.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a hysterectomy with a reprocessed harmonic scalpels/shears and the device was not coagulating correctly.We could not confirm the reported issue because the product said to be involved was not received for evaluation.As 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 2146142 and internal actions 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).
Additional Manufacturer Narrative
The product analysis lab received the device for evaluation on 21-dec-2021.Section d9 of this report was updated.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a hysterectomy with a reprocessed harmonic scalpels/shears and the device was not coagulating correctly.The device was returned sealed inside a biohazard bag along with the tray form's primary label.None of the remaining original packaging was returned.A visual inspection of the device was conducted.There was no observed structural damage to the housing or shaft of either device.The buttons appear to work normally.There were observed biological contaminants embedded within the grooves of the tissue pad and on the metal rod; the device appears to have had exposure and possible patient contact within the operative field.The tissue pad appears in proper position, whole and intact.The device was wiped clean for attachment and functional testing on the generator.The device was attached to an ethicon harmonic hp054 hand piece and was secured with a torque wrench.It was plugged into an ethicon gen11 generator.The generator noted it was identifying the device, and then displayed the message "system ready." the device was functional when the max or min hand activation buttons were pressed.The device was also tested with the jaws closed and activated on a damp tissue and a rubber band (simulating tissue) at both power modes with acceptable results; the sealing indicators could be heard.Both test items were smoothly cut.There was no indication of failure to function or seal.The reported issue is not confirmed.However, as the device was removed from its packaging and was handled within or outside the operative field, no conclusion as to the cause for the reported issue is determined.The device history record for lot 2146142 was reviewed and the device (id (b)(6)) was noted to have passed all visual and functional criteria prior to being shipped to the customer.A manufacturing record e had been conducted and 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 SCALPELS/SHEARS
• Common Device Name: ELECTROSURG, CUT/COAG ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, 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: 12962362
• Report Number: 2134070-2021-00028
• Device Sequence Number: 5410208
• Product Code: NUJ
• UDI-Device Identifier: 10888551045117
• UDI-Public: 10888551045117
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup,Followup,Followup
• Report Date (Section B): 12/08/2021

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 Expiration Date: 02/17/2023
• Device Model Number: HAR36R
• Device Catalogue Number: HAR36R
• Device Lot Number: 2146142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 12/15/2021; 12/21/2021; 01/14/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 12/20/2021; 01/13/2022; 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown