MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C2A15, GELPOINT V-PATH PLATFORM, 7CM; CULDOSCOPE (AND ACCESSORIES)

Model Number	C2A15
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	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: vnotes hysterectomy +/- lap bso.Event description: patient identified as a very narrow vaginal opening and so decision to use c2a15 to support the ring entry over their usual c2a12 for all vnotes cases.Unable to continue vnotes after performing colpotomy + usl suspension, then ring placement and insufflation as vision wasn't there once entered.Issues with insufflation on second attempt.Unstable.Stopped everything and once instruments and camera were removed, unclipped the cap to find a plastic part had fallen in the patient.After deciding the second attempt was unsuccessful, surgeons asked tech to stop the gas and they removed their instruments, unclipped the cap, and that was when the assistant surgeon recognized a clear piece came out from her area.The assistant surgeon cannot recall what instrument she had in the port but either the camera or reusable grasper.Matching it up to a missing part of the trocar, all the other trocars were assessed ensuring nothing was left in the patient.Only one plastic found and evident it had come from the one trocar as they compared them side by side with the others and recognized the difference in look/shade of the port from a bird's eye view.We recognized the insufflation was unstable during the second attempt of placing the ring but also questioned why the gas over the initial placement was not working.During this time, realizing the patient's gas over the initial period was heading straight to the abdomen, this was obvious as the abdomen was visually distended.Persevering through the second attempt to try and stabilize the gas in anyway, after 5-10 minutes, decided to stop and perform vaginal hysterectomy with the narrow opening and uterus unable to descend.Stopping the vnotes procedure and changed to a vaginal hysterectomy.The other instrument that was used when the complaint event occurred was the reusable grasper 10mm camera.There is no patient injury or illness associated with the complaint event and the patient status was not recorded on the pcf.Two images have been provided on the pcf.See complaint attachments.Additional information was received from the field team with a clarification that the plastic part being reference in the pcf was indeed from the complaint device.Intervention: stopped the vnotes procedure and changed to a vaginal hysterectomy.Patient status: no patient injury or illness associated with the complaint event.
Additional Manufacturer Narrative
No product is 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 +/- lap bso.Event description: patient identified as a very narrow vaginal opening and so decision to use c2a15 to support the ring entry over their usual c2a12 for all vnotes cases.Unable to continue vnotes after performing colpotomy + usl suspension, then ring placement and insufflation as vision wasn't there once entered.Issues with insufflation on second attempt.Unstable.Stopped everything and once instruments and camera were removed, unclipped the cap to find a plastic part had fallen in the patient.After deciding the second attempt was unsuccessful, surgeons asked tech to stop the gas and they removed their instruments, unclipped the cap, and that was when the assistant surgeon recognized a clear piece came out from her area.The assistant surgeon cannot recall what instrument she had in the port but either the camera or reusable grasper.Matching it up to a missing part of the trocar, all the other trocars were assessed ensuring nothing was left in the patient.Only one plastic found and evident it had come from the one trocar as they compared them side by side with the others and recognized the difference in look/shade of the port from a bird's eye view.We recognized the insufflation was unstable during the second attempt of placing the ring but also questioned why the gas over the initial placement was not working.During this time, realizing the patient's gas over the initial period was heading straight to the abdomen, this was obvious as the abdomen was visually distended.Persevering through the second attempt to try and stabilize the gas in anyway, after 5-10 minutes, decided to stop and perform vaginal hysterectomy with the narrow opening and uterus unable to descend.Stopping the vnotes procedure and changed to a vaginal hysterectomy.The other instrument that was used when the complaint event occurred was the reusable grasper 10mm camera.There is no patient injury or illness associated with the complaint event and the patient status was not recorded on the pcf.Two images have been provided on the pcf.See complaint attachments.Additional information was received from the field team with a clarification that the plastic part being reference in the pcf was indeed from the complaint device.Intervention: stopped the vnotes procedure and changed to a vaginal hysterectomy.Patient status: no patient injury or illness associated with the complaint event.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the dislodged shield, an internal plastic component of the sleeve was provided.Visual inspection confirmed the complainant¿s experience of shield dislodgement.Based on the description of the event and photo of the event unit, 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.

• Brand Name: C2A15, GELPOINT V-PATH PLATFORM, 7CM
• Common Device Name: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17971027
• Report Number: 2027111-2023-00646
• Device Sequence Number: 17903478
• Product Code: HEW
• UDI-Device Identifier: 00607915138493
• UDI-Public: (01)00607915138493(17)240121(30)01(10)1407858
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/10/2024

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: 01/21/2024
• Device Model Number: C2A15
• Device Catalogue Number: 101474458
• Device Lot Number: 1407858
• 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: 09/26/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• 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: 10MM CAMERA; REUSABLE GRASPERS
• Patient Sex: Unknown