MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF33, 11X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CFF33

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

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 investigation.

Event Description

Procedure performed: inguinal hernia laparascopic.Event description: the surgeon used the trocar during the entire case, it was perfectly fine.However, while removing it at the end of the case, he noticed that the tip of the cannula is broken.The surgeon removed the trocar and found that the broken piece was still hanging at the peritoneum, so he then took it out.The instruments that were used through this trocar are: a 10mm scope and few 5mm instruments (grasper and scissors).The incident did not cause any damage to the patient nor to other products.Type of intervention: component removed.Patient status:no patient injury.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided, which confirmed the complainant's experience of a cannula tip fracture.Based on the event description and the photo provided, it is likely that the cannula tip fracture was caused by an instrument (graspers or scissors), that came into contact with the cannula during the procedure.However, in the absence of the event unit, it is difficult to determine the exact root cause of the event.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: inguinal hernia laparascopic.Event description: the surgeon used the trocar during the entire case, it was perfectly fine.However, while removing it at the end of the case, he noticed that the tip of the cannula is broken.The surgeon removed the trocar and found that the broken piece was still hanging at the peritoneum, so he then took it out.The instruments that were used through this trocar are a 10mm scope and few 5mm instruments (grasper and scissors).The incident did not cause any damage to the patient nor to other products.Type of intervention: component removed.Patient status: no patient injury.

• Brand Name: CFF33, 11X100 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
• MDR Report Key: 9445311
• MDR Text Key: 177647852
• Report Number: 2027111-2019-00654
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874(17)220422(30)01(10)1353526
• Combination Product (y/n): N
• PMA/PMN Number: K083638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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 Expiration Date: 04/22/2022
• Device Model Number: CFF33
• Device Catalogue Number: 101245701
• Device Lot Number: 1353526
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 02/11/2020
• Patient Sequence Number: 1
• Treatment: 10MM SCOPE, 5MM INSTRUMENTS (GRASPER AND SCISSORS).