ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
Report
- Report Number
- 3001845648-2023-00525
- Event Type
- Malfunction
- Date Received
- June 29, 2023
- Date of Event
- April 26, 2023
- Report Date
- August 3, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002315201
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K210476. FDA MDR REPORTING NOT REQUIRED: THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿.
11:10 AM, (B)(6) 2023, PATIENT WAS UNDER GENERAL ANESTHESIA FOR ULTRASOUND BIOPSY, USER DETECTED THE NEEDLE CANNOT BE RETRACTED INTO OUTER SHEATH AFTER 3 SUCCESSFUL BIOPSY. USER THEN CHANGED TO ANOTHER SAME NEEDLE TO COMPLETE THE BIOPSY. THE ISSUE OCCURED DELAYED THE PATIENT TREATMENT WITH INFECTION RISK AND AFFECTED THE USER FACILITY STOCK. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE."
CANCELLATION REPORT TO BE SUBMITTED. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1562637 | ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE | FCG KIT, NEEDLE, BIOPSY | FCG | COOK IRELAND LTD | C1988294 | 10827002315201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |