MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF33, 11X100 KII Z-THR FIOS, 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF33
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	11/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: the trocar was being inserted into to the abdomen.Patient was undergoing laparoscopic cholecystectomy.While inserting the trocar into the abdomen, the valve got dislodged and fell into the abdomen.It was directly identified and removed.The trocar, which was leaking air now, was removed and replaced with a new one.Intervention: the valve was identified and directly removed from the abdomen.The trocar was removed and replaced with a new one.Patient status: no effect on patient, immediate action was taken.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as the unit met current specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as the returned unit met current specifications and no damages or non-conformances were found.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: the trocar was being inserted into to the abdomen.Patient was undergoing laparoscopic cholecystectomy.While inserting the trocar into the abdomen, the valve got dislodged and fell into the abdomen.It was directly identified and removed.The trocar, which was leaking air now, was removed and replaced with a new one.Additional info received from applied medical representative on 12-jan-23 via email: after contacting the hospital to make sure that the given item was the right one, the hospital and mainly the person who was responsible for giving it to us assured that the correct unit was given.The dr was asked again what he saw exactly, dr [name] said that they saw something like a 'black rubber ring' in the abdomen, so they directly assumed that it fell from the trocar, since all trocars being used were from applied medical.It was mentioned to him that none of our internal valves have a ring-like shape, and doctor was also asked for a recording or a screenshot of the piece that was seen inside the abdomen, but he said that there is none.After returning the unit for investigation and after making sure from the hospital that it was the right one, it was shown that there was no internal valve dislodgment.Doctor was asked if he thinks it might have fell from somewhere else, but he said he does not know.Intervention: the valve was identified and directly removed from the abdomen.The trocar, which was leaking air now, was removed and replaced with a new one.Patient status: no effect on patient, immediate action was taken.

• Brand Name: CTF33, 11X100 KII Z-THR FIOS, 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 15798446
• Report Number: 2027111-2022-00820
• Device Sequence Number: 14614898
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212(17)230928(30)01(10)1392867
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K041795
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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: 09/28/2023
• Device Model Number: CTF33
• Device Catalogue Number: 101472324
• Device Lot Number: 1392867
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• 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: CTF03, CLIP APPLIER
• Patient Sex: Unknown