MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF12, 5X100 KII FIOS ZTHR DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
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: lap low anterior resection.Event description: surgeon noticed a fragment of plastic in the abdomen.An obturator was removed after entry of a kii trocar and noticed the helix tip seemed to be bent or broken and the surgeon asked to sent this off for investigation to am.The fragment was not removed from the abdomen, thought to be from the damaged obturator.No suggestion was made why it was damaged, no abnormal observations before or during trocar entry and normal function of kii trocars during the procedure.Intervention: the fragment was not removed from the abdomen, thought to be from the damaged obturator.Patient status: ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant¿s experience of a broken obturator tip.The clear fragment was identified to be a portion of the obturator tip.Based on the condition of the returned unit, it is likely that the reported event was caused by the obturator being more susceptible to fracture.
Event or Problem Description
Procedure performed: lap low anterior resection.Event description: surgeon noticed a fragment of plastic in the abdomen.An obturator was removed after entry of a kii trocar and noticed the helix tip seemed to be bent or broken and the surgeon asked to sent this off for investigation to am.The fragment was not removed from the abdomen, thought to be from the damaged obturator.No suggestion was made why it was damaged, no abnormal observations before or during trocar entry and normal function of kii trocars during the procedure.Intervention: the fragment was not removed from the abdomen, thought to be from the damaged obturator patient status: ok.

• Brand Name: CTF12, 5X100 KII FIOS ZTHR DP 10/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: 13913353
• Report Number: 2027111-2022-00529
• Device Sequence Number: 3882789
• Product Code: GCJ
• UDI-Device Identifier: 00607915125707
• UDI-Public: (01)00607915125707(17)241213(30)01(10)1436235
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 05/16/2022

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: 12/13/2024
• Device Model Number: CTF12
• Device Catalogue Number: 101472858
• Device Lot Number: 1436235
• 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: 03/16/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 05/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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