MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF01, 5X150 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF01
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
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 provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: during initial insertion for fios in a laparoscopic cholecystectomy, the tip of the obturator broke off into the patient.Dr.[name] was the surgeon using the trocar.There was no patient harm, and the tip of the obturator was seen in the abdomen and recovered.The item will be available to return, after it goes through [hospital name]¿s process for defective equipment.Product return expected.Additional information received via email on 31aug2021 from applied medical account manager: the break was considered to be a clean break.It is unknown how the case was completed after the event occurred.A photo of the complaint device has been provided.Intervention: the tip of the obturator was seen in the abdomen and recovered.Patient status: there was no patient harm.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided, confirming the complainant¿s experience of a fractured obturator tip.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited non-conformance that could have contributed to the reported event in the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause of the event.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy event description: during initial insertion for fios in a laparoscopic cholecystectomy, the tip of the obturator broke off into the patient.Dr.[name] was the surgeon using the trocar.There was no patient harm, and the tip of the obturator was seen in the abdomen and recovered.The item will be available to return, after it goes through [hospital name]¿s process for defective equipment.Product return expected.Additional information received via email on 31aug2021 from applied medical account manager: the break was considered to be a clean break.It is unknown how the case was completed after the event occurred.A photo of the complaint device has been provided.Intervention: the tip of the obturator was seen in the abdomen and recovered patient status: there was no patient harm.

• Brand Name: CTF01, 5X150 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: 12418435
• Report Number: 2027111-2021-00617
• Device Sequence Number: 3577212
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014(17)231202(30)01(10)1403002
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/18/2021

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: 12/02/2023
• Device Model Number: CTF01
• Device Catalogue Number: 101412701
• Device Lot Number: 1403002
• Was Device Available for Evaluation?: No
• 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: 08/26/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown