MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C2A11, GELPOINT V-PATH PLATFORM, 11CM; CULDOSCOPE (AND ACCESSORIES)

Model Number	C2A11
Medical Device Problem Codes	Contamination (1120); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: vnotes hysterectomy w/ bilateral salpingectomy.Event description: [hospital] the staff opened the device and upon inserting the trocar, they noticed a hair on the device.Staff did not see/notice the hair when opening the original packaging.The surgeon noticed when inserting the trocar.Staff/surgeons did state that they aren't sure where the hair came from, but to be safe they wanted to open a new device.A new device was open and this device was discarded.The lot number was 1487502.The product is not available for return.Additional information received from [name] via email on 30sep2024: no patient injury or illness occurred.Date of the event was 9/27/2024.The rep was present during the case.The procedure performed was a vnotes hysterectomy w/ bilateral salpingectomy.Additional information received from [name] via email on 30sep2024: hospital contact is [name and email].Intervention: a new device was open and this device was discarded.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.Based on the description of the event, it is possible that the hairlike object originated from an operator during the manufacturing process.However, the exact root cause of the event is unknown.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.Correction: updated the component code and device code.
Event or Problem Description
Procedure performed: vnotes hysterectomy w/ bilateral salpingectomy.Event description: [hospital].The staff opened the device and upon inserting the trocar, they noticed a hair on the device.Staff did not see/notice the hair when opening the original packaging.The surgeon noticed when inserting the trocar.Staff/surgeons did state that they aren't sure where the hair came from, but to be safe they wanted to open a new device.A new device was open and this device was discarded.The lot number was 1487502.The product is not available for return.Additional information received from [name] via email on 30sep2024: no patient injury or illness occurred.Date of the event was 9/27/2024.The rep was present during the case.The procedure performed was a vnotes hysterectomy w/ bilateral salpingectomy.Additional information received from [name] via email on 30sep2024: hospital contact is [name and email].Intervention: a new device was open and this device was discarded.Patient status: no patient injury.

• Brand Name: C2A11, GELPOINT V-PATH PLATFORM, 11CM
• Common Device Name: CULDOSCOPE (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 ; 9497135359
• MDR Report Key: 20537947
• Report Number: 2027111-2024-00885
• Device Sequence Number: 8218930
• Product Code: HEW
• UDI-Device Identifier: 00607915138486
• UDI-Public: (01)00607915138486(17)260406(30)01(10)1487502
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K191294
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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 Expiration Date: 04/06/2026
• Device Model Number: C2A11
• Device Catalogue Number: 101474656
• Device Lot Number: 1487502
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TROCAR
• Patient Sex: Unknown