MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C2A12, GELPOINT V-PATH PLATFORM, 9.5 CM; CULDOSCOPE (AND ACCESSORIES)

Model Number	C2A12
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: vnotes.Event description: [hospital].There is a small clear plastic seal inside of the vnotes port.As the surgeon was passing the suture through the port the needle caught on the plastic seal and yanked it into the patient's body cavity.The surgeon saw it and removed it from the body.The device was replaced with a new one to complete the case.The lot number of the device is unknown.No patient injury occurred.The device was discarded after use, however the clear plastic piece is available for return.Additional information received from [name] via email on 24jul2024: [hospital] now orders through a warehouse, the id code is: 1030563.Type of intervention: replaced with another device (same model) to complete the case.Patient status: no patient injury.
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the shield, an internal plastic component of the sleeve, was fully dislodged from the sleeve.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by an instrument that was inserted or removed through the seal subassembly in a non-axial manner applied medical¿s instruction for use (ifu) states, ¿all instruments should be centered axially when inserted through the sleeve¿s seal for easier insertion.¿ applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: vnotes.Event description: [hospital].There is a small clear plastic seal inside of the vnotes port.As the surgeon was passing the suture through the port the needle caught on the plastic seal and yanked it into the patient's body cavity.The surgeon saw it and removed it from the body.The device was replaced with a new one to complete the case.The lot number of the device is unknown.No patient injury occurred.The device was discarded after use, however the clear plastic piece is available for return.Additional information received from [name] via email on 24jul2024: [hospital] now orders through a warehouse, the id code is: (b)(4).Additional information from [name] 10sep2024 via email the batch number is 1502495.Type of intervention: replaced with another device (same model) to complete the case.Patient status: no patient injury.

• Brand Name: C2A12, GELPOINT V-PATH PLATFORM, 9.5 CM
• 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: 19856073
• Report Number: 2027111-2024-00767
• Device Sequence Number: 8379805
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: 08/29/2026
• Device Model Number: C2A12
• Device Catalogue Number: 101474657
• Device Lot Number: 1502495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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: COMPETITOR DEVICE; GRASPER; LAPAROSCOPIC NEEDLE DRIVER; SCOPE
• Patient Sex: Unknown