MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF33, 11X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CFF33

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

Event Type  malfunction  

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 Description

Procedure performed: lower anterior resection.Event description: interoperatively dr.[name] noticed a chip missing from the distal tip of the cannula.The packaging was discarded and cannot confirm lot number.Additional information received via email on 06sep2019 from applied medical.Implementation specialist: patient status is recovering.The broken cannula was removed from the patient along with fragmented portion, a new cff33 was placed, and the surgery was completed as scheduled.Dr.[name] uses a maryland dissector, [non-applied energy device], bowel graspers, needle drivers, scissors, suction irrigation.I was not present for the case and dr.[name] does not know when, or how the fracture occurred.Per dr.[name] and team, yes, all pieces were retrieved from the patient.This port was placed in the lower right quadrant of the patient and used as an ancillary port.The method of insertion was constant downward pressure twisting in a 10-2 motion.Intervention: the broken cannula was removed from the patient along with fragmented portion, a new cff33 was placed, and the surgery was completed as scheduled patient status: no patient injury, recovering.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided, which confirmed the complainant¿s experience of a cannula tip fracture.In the absence of the event unit, it is difficult to determine the exact root cause of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: lower anterior resection.Event description: interoperatively dr.[name] noticed a chip missing from the distal tip of the cannula.The packaging was discarded and cannot confirm lot number.Additional information received via email on 06sep2019 from applied medical implementation specialist: patient status is recovering.The broken cannula was removed from the patient along with fragmented portion, a new cff33 was placed, and the surgery was completed as scheduled.Dr.[name] uses a maryland dissector, [non-applied energy device], bowel graspers, needle drivers, scissors, suction irrigation.I was not present for the case and dr.[name] does not know when, or how the fracture occurred.Per dr.[name] and team, yes, all pieces were retrieved from the patient.This port was placed in the lower right quadrant of the patient and used as an ancillary port.The method of insertion was constant downward pressure twisting in a 10-2 motion.Additional information received via email on 12sep2019 from applied medical implementation specialist: i was notified on the day of the event which was (b)(6) 2019.Intervention: the broken cannula was removed from the patient along with fragmented portion, a new cff33 was placed, and the surgery was completed as scheduled.Patient status: no patient injury, recovering.

• Brand Name: CFF33, 11X100 KII FIOS ADVFIX 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: 9010065
• MDR Text Key: 158193822
• Report Number: 2027111-2019-00585
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K083638
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CFF33
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2019
• Patient Sequence Number: 1
• Treatment: LIGASURE LF5644.