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

Model Number CTF73

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: physician complains of plastic fiber pieces coming from the trocar.They noticed the pieces on the end of their instrument.There was no visible damage to the trocar noted.There is no report of patient injury.Photos are available but the product is not available for return.Additional information received via email 23nov2021 from applied medical representative: the shavings are described to come off the inside of the plastic trocar and ending up inside the patient.Additional information received via email 24nov2021 from applied medical representative: the procedure was confirmed to be a laparoscopic cholecystectomy.Additional information received via phone 29nov2021 from applied medical representative: rep states that the issue might be related to how the facility cleans their instruments during use.Type of intervention: case was completed with the same ctf73.Patient status: there is no report of patient injury.

Event Description

Procedure performed: laparoscopic cholecystectomy.Event description: physician complains of plastic fiber pieces coming from the trocar.They noticed the pieces on the end of their instrument.There was no visible damage to the trocar noted.There is no report of patient injury.Photos are available but the product is not available for return.Additional information received via email 23nov2021 from applied medical representative: the shavings are described to come off the inside of the plastic trocar and ending up inside the patient.Additional information received via email 24nov2021 from applied medical representative: the procedure was confirmed to be a laparoscopic cholecystectomy.Additional information received via phone 29nov2021 from applied medical representative: rep states that the issue might be related to how the facility cleans their instruments during use.Type of intervention: case was completed with the same ctf73.Patient status: there is no report of patient injury.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, photos of the event unit and plastic fibers were provided, confirming the complainant¿s experience of shavings from the trocar.Based on the photos provided and the description of the event, it is likely that the reported event was caused by an instrument catching onto the inner cannula wall, scraping off fiber fragments.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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12917185
• MDR Text Key: 286954692
• Report Number: 2027111-2021-00748
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CTF73
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1