MAUDE Adverse Event Report: AESCULAP INC. AESCULAP; WRAP, STERILIZATION

Model Number	MD355
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
According to the customer: " we are having issues with holes in aesculap filters.This is an everyday occurrence.We, in (b)(6), have recommended everything possible to avoid creating holes in filters.I do understand there are areas in the filters that are light and can look like hole in filter but we are receiving reports of tiny holes.I did inspect a new bag.I put it up against a lighted magnifier.There are areas that look like tiny pin holes.".
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Correction: g4 510k number corrected.Additional information: h10 related report numbers.Investigation results: fifteen (15) samples and two (2) photographs provided were returned to the manufacturing site for technical evaluation.Results of the investigation determined that potential micro-holes were observed in the filters.Based on the investigation findings, the product met specifications.As a result, the reported failure could not be confirmed to be a manufacturing related issue.The supplier is a raw material supplier is an international organization for standardization (iso) 13485 certified supplier for sterilization packaging and infection control material and tests each lot of this filter material for porosity, permeability, and water repellency.

• Brand Name: AESCULAP
• Common Device Name: WRAP, STERILIZATION
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 22350050
• Report Number: 2916714-2025-00041
• Device Sequence Number: 15583429
• Product Code: FRG
• UDI-Device Identifier: 04046964909900
• UDI-Public: (01)04046964909900(10)C05SF001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: MD355
• Device Catalogue Number: MD355
• Device Lot Number: C05SF001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/07/2025
• 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