MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. W.O.M.; INSTRUMENT COVER; 4 7/8-3/4 X 17; PE; W/PULLUP;; DRAPE, SURGICAL

Model Number	1-519-1031
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is not available for evaluation, nor were any pictures provided.Ability to investigate was limited due to no product to evaluate.If any additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "it was reported that during the procedure, device allegedly had a small hole.There was no reported patient injury.".
Additional Manufacturer Narrative
No physical sample or photographic evidence was received from the customer to evaluate the reported failure mode.Based on the investigation conducted in order to accurately identify the section where the damage could occur, it is not possible to confirm the validity of the customer complaint at this time due to the lack of additional information such as specific location, photographs or videos.Root cause cannot be determined.If additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: W.O.M.; INSTRUMENT COVER; 4 7/8-3/4 X 17; PE; W/PULLUP
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: raghava bandi ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 21867992
• Report Number: 3002750084-2025-00016
• Device Sequence Number: 4684434
• Product Code: KKX
• UDI-Device Identifier: 00841912106035
• UDI-Public: 00841912106035
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K970889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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 Model Number: 1-519-1031
• Device Lot Number: 365489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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