MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION KII FIOS FIRST ENTRY; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number CTF33

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2020

Event Type  malfunction  

Event Description

When using trocar for laparoscopic procedure, the tip bent and had piece(s) broken off.Surgical site area was searched and palpated, and one small plastic piece retrieved; no other pieces visualized/palpated.Operative note: pre-op diagnosis: acute cholelithiasis.Post-op diagnosis: acute cholecystitis.Procedure: laparoscopic cholecystectomy with intraoperative cholangiogram technique: an incision was made using a scalpel.Veress needle was used to gain access to the peritoneum and to insufflate the abdomen.At this time, we attempted to place a 12mm trocar through the supraumbilical site.However, the tip of the trocar bent while attempting to penetrate the fascia.This trocar port site was passed off and a record was made.A 5mm port with trocar was then used to penetrate the fascia and then a second 12mm trocar was then used through the fascial defect created by the 5mm port.The laparoscope was then placed through the 12 mm trocar and showed that there was no injury to the underlying structures.Three additional 5mm port sites were then placed in the right upper quadrant, the right mid abdomen and the epigastric region.

• Brand Name: KII FIOS FIRST ENTRY
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9792351
• MDR Text Key: 182164539
• Report Number: 9792351
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212(17)220723(30)01(10)1364118
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CTF33
• Device Lot Number: 1364118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12045 DA
• Patient Weight: 79