MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR21, 5X55 KII LP OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR21
Medical Device Problem Codes	Material Fragmentation (1261); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A followup report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: gynecological procedure.Event description: [translation] on (b)(6) 2023, in the gynaecological surgery department, the tip of the trocar bent during insertion.Another trocar of the same reference was used successfully.There were no consequences for the patient.This was a repetitive incident.Additional information received by applied medical rep via email on 13sep23: they will try to have the information but, it was in gynecologia.The tip is folded.The tip is folded without particulation.Just folded.No pieces fell into patient.Yes, they stop the insertion.No robotic case.Intervention: change of device patient status: no consequences for the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a bent obturator tip.Testing was performed on the event unit and found that the wall thickness of the obturator met specifications.Based on the description of the event and condition of the returned unit, it is possible that the obturator tip bent as a result of the surgeon's method of insertion.However, the exact root cause of the bent obturator tip is unknown.The obturator tip likely cracked as a result of extended lipid exposure while in transit to and storage at applied medical.This event was reported based on the initial observation of the cracked obturator tip on the returned unit.However, based on further evaluation of the returned unit, applied medical determined that this event is not reportable as a bent obturator tip is unlikely to cause or contribute to death or serious injury and the crack obturator tip likely occurred after the event unit left the user facility.The bent obturator tip is unlikely to particulate and would likely be removed from further usage by the user.[correction] device code in section h has been updated.
Event or Problem Description
Procedure performed: gynecological procedure.Event description: [translation] on (b)(6) 2023, in the gynaecological surgery department, the tip of the trocar bent during insertion.Another trocar of the same reference was used successfully.There were no consequences for the patient.This was a repetitive incident.Additional information received by applied medical rep via email on 13sep23: they will try to have the information but it was in gynecologia the tip is folded.The tip is folded without particulation.Just folded.No pieces fell into patient.Yes they stop the insertion.No robotic case.Intervention: change of device.Patient status: no consequences for the patient.

• Brand Name: CTR21, 5X55 KII LP OPT ZTHR 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 18592231
• Report Number: 2027111-2024-00364
• Device Sequence Number: 18171964
• Product Code: GCJ
• UDI-Device Identifier: 00607915126476
• UDI-Public: (01)00607915126476(17)231230(30)01(10)1406103
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060096
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: 12/30/2023
• Device Model Number: CTR21
• Device Catalogue Number: 101179801
• Device Lot Number: 1406103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• 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: 01/03/2024
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2020
• 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
• Patient Sex: Unknown