MAUDE Adverse Event Report: Applied Medical Resources Insufflation Needle; Laparoscope, Gynecologic (And Accessories)

Model Number	C2201
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction

• Brand Name: Insufflation Needle
• Common Device Name: Laparoscope, Gynecologic (And Accessories)
• Manufacturer (Section D): Applied Medical Resources; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; +1(949)713-5359
• MDR Report Key: 50722362
• Report Number: 2027111-2026-00714
• Device Sequence Number: 8862444
• Product Code: HET
• UDI-Device Identifier: 00607915116767
• UDI-Public: (01)00607915116767
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K963359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: C2201
• Device Catalogue Number: 101465044
• Device Lot Number: 1583194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 03/27/2026
• 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 Sex: Unknown