MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF03, 5X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CFF03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hernia (2240)

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 the investigation.

Event Description

Procedure performed: obstetrics and gynecology.Event description: three complaint events occurred at the same facility: complaint 1 of 3: (b)(4) - first procedure; complaint 2 of 3: (b)(4) - second procedure; complaint 3 of 3: (b)(4) - third procedure.Report from the sales rep there are three patients who developed trocar site hernia (tsh) after surgery on (b)(6) 2022.Additional surgery was performed on all three.Cff03 is adopted in this hospital.Doctor thought that cff03 might be affected by being thicker than other companies' 5mm trocars.Second person: laparoscopic surgery was performed in (b)(6).In the same month, additional surgery was performed.[additional information]: the surgeon who experienced the tsh is the one of the top surgeon in laparoscopy.(especially for malignant cases.) additional surgery was performed on the day of all 3 cases.Currently, there is no problem and it is completely cured.All three cases were operated by same doctor.In some cases, the person who inserted the trocar was not the person himself, but he has been operating in the same way and no hernia has occurred.The surgeon never experienced tsh since he started to use cff03 in 2019.The surgeon never experienced tsh with robotic surgery although the size of the incision (robotic case use 8mm trocar) is wider than cff03.When using a balloon, the balloon is inflated and then pulled and fixed with a disc, so fascia damage occurs during pulling, and continuous pressure (pressure toward the body cavity side) is applied to the fascia by sandwiching it between the balloon and the disc.Opinion that it may lead to fascia damage.Initial investigation report: the event unit was not returned to us because the hospital disposed it, we could not confirm the unit condition.The incident information will be informed amr for further evaluation.Product is not available for return.Type of intervention: additional surgery performed, patient is ok now.Patient status: additional surgery was performed.Currently, there is no problem and it is completely cured.

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 the reported event of trocar site hernia.Based on similar events and provided information, it is likely that the incidents were not a result of device malfunction.However, the exact root cause of trocar site hernia is unknown.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: obstetrics and gynecology event description: three complaint events occurred at the same facility: complaint 1 of 3: 2022-001925 - first procedure [mfr report # 2027111 - 2022 - 00666].Complaint 2 of 3: 2022-001926 - second procedure [mfr report # 2027111 - 2022 - 00667].Complaint 3 of 3: 2022-001927 - third procedure [mfr report # 2027111 - 2022 - 00668].Report from the sales rep there are three patients who developed trocar site hernia (tsh) after surgery after june 2022.Additional surgery was performed on all three.Cff03 is adopted in this hospital.Doctor thought that cff03 might be affected by being thicker than other companies' 5mm trocars.Second person: laparoscopic surgery was performed in june.In the same month, additional surgery was performed.[additional information] ·the surgeon who experienced the tsh is the one of the top surgeon in laparoscopy.(especially for malignant cases.) · additional surgery was performed on the day of all 3 cases.Currently, there is no problem and it is completely cured.· all three cases were operated by same doctor.In some cases, the person who inserted the trocar was not the person himself, but he has been operating in the same way and no hernia has occurred.·the surgeon never experienced tsh since he started to use cff03 in 2019.The surgeon never experienced tsh with robotic surgery although the size of the incision (robotic case use 8mm trocar) is wider than cff03.When using a balloon, the balloon is inflated and then pulled and fixed with a disc, so fascia damage occurs during pulling, and continuous pressure (pressure toward the body cavity side) is applied to the fascia by sandwiching it between the balloon and the disc.Opinion that it may lead to fascia damage.Products not available for return.Type of intervention: additional surgery performed, patient is ok now.Patient status: additional surgery was performed.Currently, there is no problem and it is completely cured.

• Brand Name: CFF03, 5X100 KII FIOS ADVFIX 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: 15080065
• MDR Text Key: 296368933
• Report Number: 2027111-2022-00667
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CFF03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2022
• 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