MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF34, KII FIOS 11X100MM Z-THR W/HD 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF34
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
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: bariatric surgery.Event description: surgeon uses this device insert into an incision.Suddenly, the tip of obturator was broken.There is no impact to patient.User replace with ctr71 to complete this surgery.There is no other instruments to effect this event.Product is available for return.Additional information was received via email on 07mar2023 from distributor: the tip of the obturator broke.There was one cannula inserted using the obturator prior to the incident.No pieces fell into the patient.The trocar was inserted by rotating in an alternating clockwise and counterclockwise direction.This was not a robotic case.Intervention: user replace with ctr71 to complete this surgery.Patient status: fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a broken obturator tip.Based on the condition of the returned unit, it is likely that the reported event was caused by the obturator material, which was more susceptible to fracture.
Event or Problem Description
Procedure performed: bariatric surgery.Event description: surgeon uses this device insert into an incision.Suddenly, the tip of obturator was broken.There is no impact to patient.User replace with ctr71 to complete this surgery.There is no other instruments to effect this event.Product is available for return.Additional information was received via email on 07mar2023 from distributor: the tip of the obturator broke.There was one cannula inserted using the obturator prior to the incident.No pieces fell into the patient.The trocar was inserted by rotating in an alternating clockwise and counterclockwise direction.This was not a robotic case.Intervention: user replace with ctr71 to complete this surgery.Patient status: fine.

• Brand Name: CTF34, KII FIOS 11X100MM Z-THR W/HD 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: 16558769
• Report Number: 2027111-2023-00380
• Device Sequence Number: 6138559
• Product Code: GCJ
• UDI-Device Identifier: 00607915124229
• UDI-Public: (01)00607915124229(17)240829(30)01(10)1426914
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: 08/29/2024
• Device Model Number: CTF34
• Device Catalogue Number: 101450401
• Device Lot Number: 1426914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown