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	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2025, while the doctor was using the instrument during a laparoscopic case, "the scrub nurse quickly noted the blade had fallen/broken off the instrument and landed in the abdomen.Surgeon was able to retrieve the piece through a trocar site with a laparoscopic grasping tool." the facility reports they were "able to retrieve the broken piece without harm to the patient or delay to the procedure." no additional information at this time.The product has been requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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 facility, on (b)(6)2025, while the doctor was using the instrument during a laparoscopic case, "the scrub nurse quickly noted the blade had fallen/broken off the instrument and landed in the abdomen.Surgeon was able to retrieve the piece through a trocar site with a laparoscopic grasping tool.".

• 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: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23729858
• Report Number: 3032391-2025-00010
• Device Sequence Number: 13197309
• Product Code: NLQ
• UDI-Device Identifier: 10193489081329
• UDI-Public: 10193489081329
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HARH36RH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 77 KG