MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF73, 12X100 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CTF73

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: gastric sleeve.Event description: the rep was present for the case.They had 2 working ports in the case.The stapler went down the 12mm port.The 5mm port was being used for the camera.At the end of the case, they were pulling the stapler out of the trocar when they were finished with the 12mm port and were getting ready to suture the fascia.They noticed while looking through the camera that there was a crack at the distal end of the cannula of the 12mm trocar where it begins to taper off.They retrieved all pieces from the patient.The patient is ok and there were no injuries as a result.The trocar is available for return.Type of intervention: retrieved the pieces from the patient.Patient status: no patient injury.

Event Description

Procedure performed: gastric sleeve.Event description: the rep was present for the case.They had 2 working ports in the case.The stapler went down the 12mm port.The 5mm port was being used for the camera.At the end of the case, they were pulling the stapler out of the trocar when they were finished with the 12mm port and were getting ready to suture the fascia.They noticed while looking through the camera that there was a crack at the distal end of the cannula of the 12mm trocar where it begins to taper off.They retrieved all pieces from the patient.The patient is ok and there were no injuries as a result.The trocar is available for return.Intervention: retrieved the pieces from the patient.Patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a cannula tip fracture.Based on the condition of the returned unit and the description of the event, it is likely that the cannula tip fracture was caused by an instrument (stapler) that came into contact with the cannula tip during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CTF73, 12X100 KII FIOS ZTHR 6/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9482397
• MDR Text Key: 177628155
• Report Number: 2027111-2019-00667
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703(17)220924(30)01(10)1369060
• Combination Product (y/n): N
• PMA/PMN Number: K041795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: CTF73
• Device Catalogue Number: 101219101
• Device Lot Number: 1369060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STAPLER, 5MM APPLIED TROCAR, CAMERA