MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR03, 5X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CTR03

Device Problem Gas/Air Leak (2946)

Patient Problem Unspecified Respiratory Problem (4464)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Date of event: unknown.Procedure performed: unknown.Event description: incident occurred sometime between 07nov2021 and 13nov2021.Company representative states the procedure may have been a kidney transplant.What is known is that the procedure was around 400 minutes long.The customer complains the trocar seal was leaking.The patient's serum (b)(6) continued to rise significantly, delaying extubation, and requiring intensive care.The product was discarded at the hospital and is not available for return.Additional information received via email from user facility on (b)(6) 2021: physician states the seal inside one of the new trocars was leaking persistently, noting that several tanks of (b)(6) were used before realizing and swapping out the trocar.Physician also mentions, during the case, "the patient's serum (b)(6) continued to rise significantly, to the point that anesthesia was becoming concerned about his ventilation and it ended up delaying his extubating and requiring him to go to the icu.At the end of the case he had a significant amount of subcutaneous crepitus throughout the torso and upper extremities (from (b)(6))." type of intervention: patient required treatment in icu patient status: patient had significant amount of subcutaneous crepitus throughout the torso and upper extremities (from (b)(6)).

Event Description

Date of event: unknown.Procedure performed: unknown.Event description: incident occurred sometime between (b)(6) 2021 and (b)(6) 2021.Company representative states the procedure may have been a kidney transplant.What is known is that the procedure was around 400 minutes long.The customer complains the trocar seal was leaking.The patient's serum co2 continued to rise significantly, delaying extubation, and requiring intensive care.The product was discarded at the hospital and is not available for return.Additional information received via email from user facility on 16nov2021: physician states the seal inside one of the new trocars was leaking persistently, noting that several tanks of co2 were used before realizing and swapping out the trocar.Physician also mentions, during the case, "the patient's serum co2 continued to rise significantly, to the point that anesthesia was becoming concerned about his ventilation and it ended up delaying his extubating and requiring him to go to the icu.At the end of the case he had a significant amount of subcutaneous crepitus throughout the torso and upper extremities (from co2)." type of intervention: patient required treatment in icu.Patient status: patient had significant amount of subcutaneous crepitus throughout the torso and upper extremities (from co2).

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to seal leakage.Based on input received from applied medical clinical subject matter experts, it is unlikely that seal leakage would have caused or contributed to the patient outcome.Applied medical has reviewed the details surrounding the event and is unable to determine the cause of the injury or identify any reason why seal leakage could have caused or contributed to the injury.

• Brand Name: CTR03, 5X100 KII OPT 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: 12865412
• MDR Text Key: 286245113
• Report Number: 2027111-2021-00734
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CTR03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Other