MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. ENDOCAVITY PROBE COVER; 3.5CM X 20CM

Model Number	1-519-3230CI
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "the item # is 934412 and our clinical staff has been finding holes in them when they put the probe cover over the probe.You can't see the holes until the cover is stretched out, if that makes sense.".
Additional Manufacturer Narrative
The device is in process of being returned for evaluation, and the investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.

• Brand Name: ENDOCAVITY PROBE COVER; 3.5CM X 20CM
• Common Device Name: ENDOCAVITY PROBE COVER
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 25164579
• Report Number: 3002750084-2026-00044
• Device Sequence Number: 10567514
• Product Code: KKX
• UDI-Device Identifier: 60841912100882
• UDI-Public: 60841912100882
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K970891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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: 1-519-3230CI
• Device Lot Number: 439530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown