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

Model Number CTF73

Device Problem Material Fragmentation (1261)

Patient Problems Post Operative Wound Infection (2446); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2022

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 the investigation.

Event Description

Procedure performed: unknown.Event description: during insertion of the trocar, the tip of the device cracked and a piece of plastic may be retained in the patients.Patient status: piece of plastic may be retained in the patients.

Event Description

Procedure performed: emergency division of adhesional small bowel obstruction.Event description: during insertion of the trocar, the tip of the device cracked and a piece of plastic may be retained in the patients.Additional information received from applied medical representative via email 09sep22: additional information from the user facility.The patient is home, she had a wound infection in that port site, and still complains of worse pain in that wound compared to the others.I was holding the camera in my right hand looking at the screen and pushing with my left holding the port, rotating as described above (rotated in alternating clockwise and counterclockwise direction) ¿ it was possible that while doing that i was also pushing with my right hand as i was quite tense ¿ this is a procedure i avoid doing and am always scared by as i¿ve seen cases where the scope has ended inside the bowel.There was difficulty during insertion.I was pushing quite hard and not making progress through the layers.The break was not considered to be a clean break.A 0.5cm disc of the port appeared missing.The break did not cause particulation.All pieces were not retrieved from the patient.The trocar was not used with a robot.A 10mm camera was inside the cannula at the time of the incident.Additional information received from applied medical representative via email 16sep22: the patient continues to receive care and is scheduled for follow-ups due to infection: a course of antibiotics, further ultrasound, 2 further hot clinic reviews and she is still awaiting an extra outpatient review.The infection was treated with iv followed by oral antibiotics additional information received from applied medical representative via email 11oct22: the only incident device is the ctf73, no other trocar was sent in for evaluation.Customer confirmed it was the obturator that broke, not the cannula.Additional information received from applied medical representative via email 14oct22: additional information from the consultant."i saw her again in clinic.She is still complaining of pain at the involved port site.The wound itself looks well healed, but we cant be sure if there is a piece left behind, not least if it is there if it is the cause of her pain.She seemed very adamant that she didn¿t want a piece of plastic left in her.I tried to explain that we do intentionally leave pieces of plastic in patients frequently, and the risks of another operation are much greater that the risks of leaving it inside, but she didn¿t seem convinced.I have arranged a ct to try to look for it." type of intervention: the infection was treated with iv followed by oral antibiotics patient status: piece of plastic may be retained in the patients.The patient is home, she had a wound infection in that port site, and still complains of worse pain in that wound compared to the others.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a broken obturator tip.Based on the condition of the returned unit and the description of the event, it is possible that that the broken obturator tip was due to excessive force exerted on the tip during insertion, the material of the tip being more susceptible to fracture, or a combination of both.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Updated section g2, health impact code, and health clinical code.

• 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: 15422168
• MDR Text Key: 306258800
• Report Number: 2027111-2022-00731
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703(17)240912(30)01(10)1426897
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K041795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CTF73
• Device Catalogue Number: 101219101
• Device Lot Number: 1426897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1