MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR33, 11X100 KII OPT ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CFR33

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be send upon completion of investigation.

Event Description

Procedure performed: lap sleeve.Event description: limited information was available at the time of reporting.Rep.Wasn't present for the case.Stated that during the procedure, the tip of the cannula fractured and it did cause particulation as the surgeon had to remove the two broken pieces from the patient.Whether or not the trocar was used with a robot or as an ancillary port is unknown.Both method of insertion and intervention are also unknown.There was no patient injury and the product is not expected to return.Patient status: no patient injury occurred.

Manufacturer Narrative

Correction: the event description was revised to reflect the correct date the information was received from the user facility and applied medical representative.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: lap.Sleeve.Event description: complaint information received from user facility via email on october 8, 2019: "we had a trocar break in a patient yesterday when they were trying to put it in.They had to dig pieces of it out of the abdominal cavity.I have it in my office if you need it.Just wanted to bring this to your attention!" additional information received from applied medical representative via telephone on october 22, 2019: limited information was available at the time of reporting.Rep.Wasn't present for the case.Stated that during the procedure, the tip of the cannula fractured and it did cause particulation as the surgeon had to remove the two broken pieces from the patient.Whether or not the trocar was used with a robot or as an ancillary port is unknown.Both method of insertion and intervention are also unknown.Photos are available.The product is not expected to return.Patient status: no patient injury occurred.

• Brand Name: CFR33, 11X100 KII OPT 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: 9242289
• MDR Text Key: 177770119
• Report Number: 2027111-2019-00620
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CFR33
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2019
• Patient Sequence Number: 1