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	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: hysterectomy with double adnexectomy, myomatous uterus.Event description: the revision of the cavity was being carried out, after removing the uterus and annexes, at that moment it was discovered that part of the trocar seal was loose inside.The part of the trocar that has detached (inner white plastic seal) is removed, a photo of the products is attached.The defective trocar is used during the entire intervention for optics in the six o´clock position.The hospital documents the case just by sending a photo and discards the device.Intervention: the part of the trocar that has detached (inner white plastic seal) is removed.Patient status: favorable.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the shield, an internal plastic component of the sleeve was provided, confirming the complainant¿s experience of shield dislodgement.Based on the description of the event, it is likely that the shield dislodgement was caused by non-axial insertion or removal of asymmetrical instrumentation through the sleeve.Applied medical¿s instructions for use (ifu) states that, "extra care should be taken when inserting and withdrawing angular and asymmetrical instruments, such as 'j' hooks and clip appliers." the ifu also states, "all instruments should be centered axially when inserted through the seal." the probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: hysterectomy with double adnexectomy, myomatous uterus.Event description: the revision of the cavity was being carried out, after removing the uterus and annexes, at that moment it was discovered that part of the trocar seal was loose inside.The part of the trocar that has detached (inner white plastic seal) is removed, a photo of the products is attached.The defective trocar is used during the entire intervention for optics in the six o´clock position.The hospital documents the case just by sending a photo and discards the device.Intervention: the part of the trocar that has detached (inner white plastic seal) is removed.Patient status: favorable.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16615281
• Report Number: 2027111-2023-00401
• Device Sequence Number: 15016513
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660(17)251106(30)01(10)1471738
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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: 11/06/2025
• Device Model Number: C2A12
• Device Catalogue Number: 101474456
• Device Lot Number: 1471738
• Was Device Available for Evaluation?: No
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• 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