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U.S. Department of Health and Human Services

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

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APPLIED MEDICAL RESOURCES CORPORATION KII FIOS FIRST ENTRY LAPAROSCOPE, GENERAL PLASTIC SURGERY Back to Search Results
Model Number CTF33
Device Problems Break (1069); Material Twisted/Bent (2981); Handpiece (3067); Tip (3123)
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.

 
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Brand NameKII FIOS FIRST ENTRY
Type of DeviceLAPAROSCOPE, GENERAL PLASTIC SURGERY
Manufacturer (Section D)
APPLIED MEDICAL RESOURCES CORPORATION
22872 avenida empresa
rancho santa margarita CA 92688
MDR Report Key9792351
MDR Text Key182164539
Report Number9792351
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received03/05/2020
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCTF33
Device LOT Number1364118
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/11/2020
Event Location Hospital
Date Report TO Manufacturer03/05/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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