MAUDE Adverse Event Report: MEDLINE RENEWAL; HARMONIC ACE+7 SHEARS 5MM X 36CM

Catalog Number	HARH36RH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, during a "laparoscopic procedure, the white piece inside the jaws of the reprocessed harmonic came off inside the patient's abdomen." the customer stated, "it looked as if it partially melted" and "the piece was retrieved, and they opened a different harmonic." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, during a "laparoscopic procedure, the white piece inside the jaws of the reprocessed harmonic came off inside the patient's abdomen.".

• Common Device Name: HARMONIC ACE+7 SHEARS 5MM X 36CM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 94456 1876
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23639870
• Report Number: 3032391-2025-00008
• Device Sequence Number: 13221793
• Product Code: NLQ
• UDI-Device Identifier: 10193489081329
• UDI-Public: 10193489081329
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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 Catalogue Number: HARH36RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown