MAUDE Adverse Event Report: MEDLINE RENEWAL HARMONIC ACE+7 SHEARS W/ ADV. HEMOSTASIS; HARMONIC ACE+7 SHEARS 5MM X 36CM

Catalog Number	HARH36R
Medical Device Problem Codes	Material Fragmentation (1261); Peeled/Delaminated (1454); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, per staff in the room, a piece of plastic broke was retrieved.While inactive the blade started to peel.The instrument was entirely too hot entire shaft was too hot to even touch.
Additional Manufacturer Narrative
It was reported that, per staff in the room, a piece of plastic broke was retrieved.While inactive the blade started to peel.The instrument was entirely too hot entire shaft was too hot to even touch.There were no reports of death, serious injury, medical intervention, or follow up care.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.

• Brand Name: HARMONIC ACE+7 SHEARS W/ ADV. HEMOSTASIS
• 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: meghana maddilli ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25194832
• Report Number: 3032391-2026-00011
• Device Sequence Number: 10433674
• Product Code: NLQ
• UDI-Device Identifier: 10193489081329
• UDI-Public: 10193489081329
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K193563
• 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): 05/15/2026

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
• Device Catalogue Number: HARH36R
• Device Lot Number: 563224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2026
• 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