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 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to return for evaluation.A follow-up report will be sent upon completion of investigation.

Event Description

Procedure performed: total laparoscopic hysterectomy.Event description: towards the end of the case with mr [name], the surgical assistant noticed that there was a piece of plastic missing from the end of the port.A general surgery consultant was called in to assist in finding the missing piece of plastic.The general consultant found the piece of plastic laying on a loop of the bowel.No noticeable injury to the bowel, just laying flat on top.The port was the first port used and used for only the camera and with 1 x suture.The plastic piece removed from the patient fits to the broken cannula and it is believe that all plastic has been removed from the patient.Intervention: retrieval of fragmented part.Patient status: no patient injury.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation along with a green plastic fragment.Visual inspection confirmed the complainant¿s experience of a cannula tip fracture.The plastic fragment matched the missing portion at the cannula tip.Based on the condition of the returned unit and the description of the event, it is likely that the damage was caused by an instrument or object that came into contact with the cannula tip 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.Common device name was corrected.

Event Description

Procedure performed: total laparoscopic hysterectomy.Event description: towards the end of the case with mr [name], the surgical assistant noticed that there was a piece of plastic missing from the end of the port.A general surgery consultant was called in to assist in finding the missing piece of plastic.The general consultant found the piece of plastic laying on a loop of the bowel.No noticeable injury to the bowel, just laying flat on top.The port was the first port used and used for only the camera and with 1 x [] suture.The plastic piece removed from the patient fits to the broken cannula and it is believe that all plastic has been removed from the patient.Intervention: retrieval of fragmented part.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: 8664967
• MDR Text Key: 151288105
• Report Number: 2027111-2019-00465
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874(17)211126(30)01(10)1342396
• 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: 06/03/2019

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: 11/26/2021
• Device Model Number: CFF33
• Device Catalogue Number: 101245701
• Device Lot Number: 1342396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCOPE, V-LOC SUTURE