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

Model Number CTF73

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procedure performed: laparoscopic vats.Event description: "approximately mid way through a vats procedure two 12 mm canulae experienced problems." "[the cannula] broke nearly in half." "the patient was not injured, and the actual event samples were thrown away, so will not be sent in to the home office.Also, the lot numbers were not recorded.The thoracic coordinator is not able to give me any additional information.This event occured during the covid 19 pandemic." additional information received via email on 06may2020 from applied medical health system is."the case was not robotic and the fractures occurred during the procedure, not at insertion.The fractures did not cause particulation.My contact doesn¿t know if instruments were being used through the trocars when the fractures occurred.The affected trocars were replaced after the incidents occurred." patient status: no patient injury.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, which confirmed the complainant¿s experience of a fractured cannula.The fractured cannula from the photograph was connected at a single location.In the absence of the event unit, it is difficult to determine if the fractured cannula was a result of a device non-conformance.However, based on the photographs provided and the description of the event, it is likely that the location of the trocar placement caused excessive forces to be exerted on the cannula when it was maneuvered 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.

Event Description

Procedure performed: laparoscopic vats event description: "approximately mid way through a vats procedure two 12 mm canulae experienced problems." "[the cannula] broke nearly in half." "the patient was not injured, and the actual event samples were thrown away, so will not be sent in to the home office.Also, the lot numbers were not recorded.The thoracic coordinator is not able to give me any additional information.This event occured during the covid 19 pandemic." additional information received via email on 06may2020 from applied medical health system is."the case was not robotic and the fractures occurred during the procedure, not at insertion.The fractures did not cause particulation.My contact doesn¿t know if instruments were being used through the trocars when the fractures occurred.The affected trocars were replaced after the incidents occurred." patient status: no patient injury.

• 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: 10033680
• MDR Text Key: 190316736
• Report Number: 2027111-2020-00462
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 06/03/2020
• Patient Sequence Number: 1