MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF74, KII 12X100 FIOS Z-THR HN 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF74
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Event description: [translation]: difficulties inserting the laparo trocar into the abdomen because the tip of the obturator is not compliant (curved).Impossible to access the abdominal wall.Change of trocar.Intervention: change of trocar.Patient status: no patient injury has been reported.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a broken fragment.Visual inspection confirmed the complainant's experience of a bent obturator tip, as the fragment returned was identified to be the obturator tip and was bent.Based on the description of the event and condition of the returned unit, it is possible that the obturator tip bent due to coming in contact with a hard surface or anatomical structure during insertion.However, the exact root cause of the bent obturator tip is unknown.The obturator tip likely fractured as a result of prolonged lipid exposure while in transit back to applied medical.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This event was reported based on the initial observation of the fractured 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.The bent obturator tip is unlikely to particulate and would likely be removed from further usage by the user.
Event or Problem Description
Procedure performed: unknown.Event description: [translation].Difficulties inserting the laparo trocar into the abdomen because the tip of the obturator is not compliant (curved).Impossible to access the abdominal wall.Change of trocar.Intervention: change of trocar.Patient status: no patient injury has been reported.

• Brand Name: CTF74, KII 12X100 FIOS Z-THR HN 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: 15818755
• Report Number: 2027111-2022-00824
• Device Sequence Number: 7133265
• Product Code: GCJ
• UDI-Device Identifier: 00607915123710
• UDI-Public: (01)00607915123710(17)250320(30)01(10)1445096
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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: 03/20/2025
• Device Model Number: CTF74
• Device Catalogue Number: 1445096
• Device Lot Number: 1445096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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