MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY?; Universal Cutter

Model Number	7060
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction

• Brand Name: ACUITY?
• Common Device Name: Universal Cutter
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INCORPORATED; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50658083
• Report Number: 2124215-2026-45674
• Device Sequence Number: 13117856
• Product Code: DQY
• UDI-Device Identifier: 08714729936176
• UDI-Public: (01)08714729936176(11)260219(17)280202(10)H3367412
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K080154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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
• Operator of Device: Health Professional
• Device Model Number: 7060
• Device Catalogue Number: 7060
• Device Lot Number: H3367412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Supplement Date Received by Manufacturer: 09/22/2026; 09/03/2026
• Initial Report FDA Received Date: 09/07/2026
• Supplement Report FDA Received Date: 09/23/2026; 09/29/2026
• Date Device Manufactured: 02/19/2026
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Unknown