MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF03, 5X100 KII FIOS Z-THR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF03
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
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: removal of gastric band.Event description: [surgeon name redacted] was inserting the port into the patient in order to put in a liver retractor.[senior odp name redacted] was sitting next to the patient and noticed the obturator start to bend when [surgeon name redacted] was inserting it.The odp notified [surgeon name redacted] and when [surgeon name redacted] removed the obturator from the sleeve he didn't seem to think it had snapped.When he passed the obturator to the odp on inspection the trocar had broken on one side and was still attached the other side, so a partial break.The odp said as soon as there was pressure at the tip of the obturator you could notice the defect higher up in the sleeve.Additional information received by applied medical rep.On 14sep2022: the surgeon wanted to make an opening to insert a liver retractor in order to do this he only uses the obturator without the sleeve so he only has a small fascial defect.The 5mm obturator was inserted and the obturator bent, when it was removed it was noticed that the trocar had snapped on one side.No sleeves were used in conjunction with the obturator so the initial report was incorrect.Patient status: patient had normal recovery.
Event or Problem Description
Procedure performed: removal of gastric band.Event description: [surgeon] was inserting the port into the patient in order to put in a liver retractor.[senior odp] was sitting next to the patient and noticed the obturator start to bend when [surgeon] was inserting it.The odp notified [surgeon] and when [surgeon] removed the obturator from the sleeve he didn't seem to think it had snapped.When he passed the obturator to the odp on inspection the trocar had broken on one side and was still attached the other side, so a partial break.The odp said as soon as there was pressure at the tip of the obturator you could notice the defect higher up in the sleeve.Additional information received by applied medical representative via email on 14sep2022: the surgeon wanted to make an opening to insert a liver retractor in order to do this he only uses the obturator without the sleeve so he only has a small fascial defect.The 5mm obturator was inserted and the obturator bent, when it was removed it was noticed that the trocar had snapped on one side.No sleeves were used in conjunction with the obturator so the initial report was incorrect.Patient status: patient had normal recovery.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a broken obturator shaft.The wall thickness of the shaft was measured and met specifications.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was due to use error.The obturator is not designed for insertion without the cannula, as the cannula provides additional structural integrity.It is likely that the obturator shaft was unable to withstand the force exerted on it during insertion without the cannula, causing it to fracture.

• Brand Name: CTF03, 5X100 KII FIOS Z-THR 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: 15506158
• Report Number: 2027111-2022-00747
• Device Sequence Number: 5212171
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)250118(30)01(10)1439958
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: 01/18/2025
• Device Model Number: CTF03
• Device Catalogue Number: 101138401
• Device Lot Number: 1439958
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RETRACTOR
• Patient Sex: Unknown