CTF33, 11X100 KII FIOS ZTHR 6/BX
Report
- Report Number
- 2027111-2023-00768
- Event Type
- Malfunction
- Date Received
- November 20, 2023
- Date of Event
- October 27, 2023
- Report Date
- February 15, 2024
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCJ
- UDI-DI
- 00607915124212
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF A BROKEN OBTURATOR TIP. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY THE OBTURATOR MATERIAL, WHICH WAS MORE SUSCEPTIBLE TO FRACTURE.
THE EVENT UNIT IS ANTICIPATED TO RETURN TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.
PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: "LAST FRIDAY DR [NAME] USED ONE CTF33 DURING HER CASE AND ONCE SHE INSERTED THE TROCAR THEY NOTICED BLOOD INSIDE THE TROCAR, THE BLUNT TROCAR IS BROKEN AND SHARP ON THE DISTAL TIP. THEY CHECKED THE PACKAGING AND PATIENT FOR THE MISSING PLASTIC PIECES AND NO TRACES FOUND" PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 15NOV2023 PER HEALTH CANADA REPORT # 1070351: [TRANSLATION OF INCIDENT DESCRIPTION] THE SURGEON NOTICES WHEN SHE ENTERS THE OPERATING LENS WITH THE TROCAR THAT THERE IS LIQUID COMING OUT THROUGH THE FIRST ENTRY TROCAR. THIS IS NOT NORMAL BUT STILL DOES THE SURGERY BEFORE THE TROCAR. AT THE END OF THE CASE WE NOTICED THAT A SMALL PIECE OF PLASTIC WAS MISSING FROM THE TROCAR CANNULA. IT IS ASSUMED THAT THE PIECE OF PLASTIC WAS MISSING BEFORE SURGERY BUT WE ARE NOT CERTAIN. THE SURGEON CHECKED THE ABDOMEN AND FOUND NO PLASTIC PIECES IN THE ABDOMEN. ADDITIONAL INFORMATION RECEIVED ON 16NOV2023 VIA EMAIL FROM ACCOUNT MANAGER: NO PATIENT INJURY OCCURRED. DISTAL TIP OF OBTURATOR BROKE. THE TROCAR WAS INSERTED USING THE RECOMMENDED TECHNIQUE. THERE WAS NO DIFFICULTY DURING INSERTION. THE CASE WAS NOT ROBOTIC. INTERVENTION: THEY CHECKED THE PACKAGING AND PATIENT FOR THE MISSING PLASTIC PIECES AND NO TRACES FOUND. PATIENT STATUS: NO PATIENT INJURY OCCURRED.
PROCEDURE PERFORMED: UNKNOWN EVENT DESCRIPTION: "LAST FRIDAY DR [NAME] USED ONE CTF33 DURING HER CASE AND ONCE SHE INSERTED THE TROCAR THEY NOTICED BLOOD INSIDE THE TROCAR, THE BLUNT TROCAR IS BROKEN AND SHARP ON THE DISTAL TIP. THEY CHECKED THE PACKAGING AND PATIENT FOR THE MISSING PLASTIC PIECES AND NO TRACES FOUND" PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED ON 15NOV2023 PER HEALTH CANADA REPORT # 1070351: [TRANSLATION OF INCIDENT DESCRIPTION] THE SURGEON NOTICES WHEN SHE ENTERS THE OPERATING LENS WITH THE TROCAR THAT THERE IS LIQUID COMING OUT THROUGH THE FIRST ENTRY TROCAR. THIS IS NOT NORMAL BUT STILL DOES THE SURGERY BEFORE THE TROCAR. AT THE END OF THE CASE WE NOTICED THAT A SMALL PIECE OF PLASTIC WAS MISSING FROM THE TROCAR CANNULA. IT IS ASSUMED THAT THE PIECE OF PLASTIC WAS MISSING BEFORE SURGERY BUT WE ARE NOT CERTAIN. THE SURGEON CHECKED THE ABDOMEN AND FOUND NO PLASTIC PIECES IN THE ABDOMEN. ADDITIONAL INFORMATION RECEIVED ON 16NOV2023 VIA EMAIL FROM ACCOUNT MANAGER: NO PATIENT INJURY OCCURRED. DISTAL TIP OF OBTURATOR BROKE. THE TROCAR WAS INSERTED USING THE RECOMMENDED TECHNIQUE. THERE WAS NO DIFFICULTY DURING INSERTION. THE CASE WAS NOT ROBOTIC. INTERVENTION: THEY CHECKED THE PACKAGING AND PATIENT FOR THE MISSING PLASTIC PIECES AND NO TRACES FOUND. PATIENT STATUS: NO PATIENT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2165762 | CTF33, 11X100 KII FIOS ZTHR 6/BX | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | APPLIED MEDICAL RESOURCES | CTF33 | 1494634 | 00607915124212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |