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

Model Number	CTF33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
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: lap gastric sleeve.Event description: a resident was placing the trocar (correctly, by all accounts) under dr.[name]'s direct supervision when the obturator snapped off at the tip of the shaft.The obturator had not reached the peritoneum, so the broken piece was easily removed from the incision.Additional information was received via email on 11jan2023 from applied medical representative: the break occurred at the obturator shaft.The obturator was inside the cannula at the time of the incident.There were no cannulas inserted using the obturator prior to the incident.The break was not clean, it was jagged.The snapped piece was retrieved from the patient.The trocar was inserted "correctly".There was no difficulty during insertion.The case was not robotic.Product available for return.Intervention: used another trocar.Patient status: unharmed.
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.The obturator tip was fractured.Based on the description of the event and the condition of the returned unit, it is likely that the obturator tip fractured due to excess force exerted on the tip during insertion.It is also possible that the obturator material, which was more susceptible to fracture, was a contributing factor.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: lap gastric sleeve.Event description: a resident was placing the trocar (correctly, by all accounts) under dr.[name]'s direct supervision when the obturator snapped off at the tip of the shaft.The obturator had not reached the peritoneum, so the broken piece was easily removed from the incision.Additional information was received via email on 11jan2023 from applied medical representative: the break occurred at the obturator shaft.The obturator was inside the cannula at the time of the incident.There were no cannulas inserted using the obturator prior to the incident.The break was not clean, it was jagged.The snapped piece was retrieved from the patient.The trocar was inserted "correctly".There was no difficulty during insertion.The case was not robotic.Product available for return.Intervention: used another trocar.Patient status: unharmed.

• Brand Name: CTF33, 11X100 KII FIOS 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 16164598
• Report Number: 2027111-2023-00319
• Device Sequence Number: 7396749
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212(17)251006(30)01(10)1466420
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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: 10/06/2025
• Device Model Number: CTF33
• Device Catalogue Number: 101219301
• Device Lot Number: 1466420
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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