MAUDE Adverse Event Report: AESCULAP INC. ROUND FILTERS W/INDICATOR

Model Number US751

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

Event 7.It was reported to aesculap inc.That a round filters w/indicator (part# us751) was used with a sterilization container provided for use during an unspecified surgical procedure on (b)(6) 2023.According to the complainant the or staff found small holes in the sterile container filters.Reportedly this caused a delay in the surgical procedure.The adverse event is filed under aic reference (b)(4).Associated medwatch reports: (b)(4) (2916714-2023-00133) us751 event 1.(b)(4) (2916714-2023-00134) us751 event 2.(b)(4) (2916714-2023-00135) us751 event 3.(b)(4) (2916714-2023-00136) us751 event 4.(b)(4) (2916714-2023-00137) us751 event 5.(b)(4) (2916714-2023-00138) us751 event 6.(b)(4) (2916714-2023-00140) us751 event 1.(b)(4) (2916714-2023-00141) us751 event 2.

Manufacturer Narrative

Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Event 7.Additional information: h6 codes updated.D9 returned to manufacturer.Investigation results: the device record cannot be evaluated due to lack of lot code information.The samples that were returned, no visible micro pinholes.No further action will be taken at this time, not a manufacturing defect.Root cause investigation: customer was asked how they are evaluating the product, response "by putting up to the light or in the or and seeing if they can see any pinholes.They were actually rejecting sets based on shades of color in the filters to but i pointed out to them this was overkill" this is not the proper way to evaluate the pinholes, the changes in color if filter material is expected.

• Brand Name: ROUND FILTERS W/INDICATOR
• Type of Device: ROUND FILTERS W/INDICATOR
• 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: 18371674
• MDR Text Key: 331090542
• Report Number: 2916714-2023-00139
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 04038653473724
• UDI-Public: 4038653473724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly