MAUDE Adverse Event Report: STERILMED, INC. HARMONIC SCALPELS/SHEARS; ELECTROSURGICAL, CUTTING/COAGULATION ACC, LAPAROSCOP/ENDOSCOP, REPROCESSED

Model Number	HAR36R
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that a patient underwent a gastric sleeve procedure with reprocessed harmonic scalpels/shears and the device was not providing adequate hemostasis.During the procedure the device was cutting but not coagulating.The device was replaced, and the procedure was continued and completed successfully with no patient consequence.There was no delay due to the issue.The patient has fully recovered.
Additional 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.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
It was reported that a patient underwent a gastric sleeve procedure with reprocessed harmonic scalpels/shears and the device was not providing adequate hemostasis.The returned device was examined.There was no observed structural damage to the housing or shaft of the device.The buttons appear to work normally.There were observed biological contaminants and eschar on the metal rod and the tissue pad, indicative of exposure within the operative field.The tissue pad appeared in proper position, whole and intact.The device was wiped clean for further inspection, including removing the tissue build-up on the metal cutting rod.The device was then attached to an ethicon harmonic hp054 hand piece and was secured with a returned torque wrench, which appeared whole and intact.It was plugged into generator g11.The generator noted it was identifying the device, displayed the message "system ready" and the device was able to fire.The device was actuated on a damp tissue and the sealing indicator tones were heard and there were no generated and displayed errors.There was evidence of sealing present (the build-up of eschar and burnt biological tissue on the cutting blade) and there was no evidence that the device had malfunctioned, the reported issue was not confirmed.Per the instructions for use reprocessed harmonic ace® shears with adaptive tissue technology, "for optimal performance, clean the instrument blade and clamp arm throughout the procedure by activating the instrument tip in sterile saline.The instrument can be wiped with a sterile moist gauze sponge to remove tissue, if necessary.Warning: do not touch the instrument to metal while activated." no manufacturing record evaluation was conducted as there was no lot number provided.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: ELECTROSURGICAL, CUTTING/COAGULATION ACC, LAPAROSCOP/ENDOSCOP, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 11467762
• Report Number: 2134070-2021-00005
• Device Sequence Number: 11661982
• Product Code: NUJ
• UDI-Device Identifier: 10888551045117
• UDI-Public: 10888551045117
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/18/2021; 04/15/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/14/2021; 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1