DISPOSABLE HIGH SPEED TDC CUTTER 25 G / 8000 CPM DORC CONTINUUM RANGE
Report
- Report Number
- 1222074-2021-00090
- Event Type
- Malfunction
- Date Received
- November 10, 2021
- Date of Event
- October 7, 2021
- Report Date
- March 7, 2022
- Manufacturer
- D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
- Product Code
- HQC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE COMPLAINT IS UNDER INVESTIGATION.
IN REGARD TO THE COMPLAINT, ONE 25 GAUGE DISPOSABLE HIGH SPEED TDC CUTTER WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED VITRECTOME REVEALED SOME FOREIGN MATERIAL IN THE ASPIRATION TUBE THAT INDICATED THAT THE INSTRUMENT HAD BEEN USED. RIGOROUS TESTING SHOWED THAT THERE WAS A PARTIAL OBSTRUCTION IN THE CUTTER THAT COMPROMISED THE ASPIRATION FLOW. THE OBSTRUCTION WAS MOST LIKELY THE RESULT OF ACCUMULATION OF SURGICAL RESIDUE. DEVICE HISTORY RECORD REVIEW REVEALED NO DEVIATIONS AND A DATABASE SEARCH SHOWED THAT NO SIMILAR COMPLAINTS HAVE BEEN REPORTED ON THIS SPECIFIC LOT PREVIOUSLY. IT SHOULD BE NOTED THAT, DURING VITRECTOMY SURGERY, IT IS QUITE COMMON FOR SMALL BUBBLES TO FORM DUE TO FRICTION OF THE BLADES. USUALLY, THESE BUBBLES ARE IMMEDIATELY ASPIRATED; HOWEVER, WHEN ASPIRATION SETTINGS ARE TOO LOW OR WHEN THE ASPIRATION FUNCTION IS COMPROMISED THEY MAY ENTER THE PATIENTS' EYE. THOUGH THESE BUBBLES ARE INCONVENIENT, THE PHENOMENON IS RARE AND PATIENT HARM IS NOT CONSIDERED LIKELY. BASED ON THE INVESTIGATION PERFORMED, A MANUFACTURER RELATED FAILURE COULD NOT BE CONFIRMED.THE RISK IDENTIFIED IS INCLUDED IN THE RISK MANAGEMENT DOCUMENTATION. TREND ANALYSIS INDICATES THAT THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. THEREFORE, NO REMEDIAL OR CORRECTIVE/PREVENTIVE ACTIONS WILL BE UNDERTAKEN AT THIS MOMENT. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS.
THE COMPLAINT IS UNDER INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED/ ACCESSIBLE FOR INVESTIGATION YET. THE INVESTIGATION WILL BE CONTINUED WHEN THE DEVICE IS AVAILABLE FOR EXAMINATION. SEVERAL PRODUCT REMINDERS ARE SENT TO RECEIVE THE PRODUCT FOR INVESTIGATION.
THE DEVICE SUBJECT TO THIS EVENT WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
IT WAS REPORTED THAT DURING A VITRECTOMY PROCEDURE BUBBLES ENTERED THE PATIENTS EYE FROM THE TIP OF THE VITRECTOMY CUTTER. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MIN.
IT WAS REPORTED THAT DURING A VITRECTOMY PROCEDURE BUBBLES ENTERED THE PATIENTS EYE FROM THE TIP OF THE VITRECTOMY CUTTER. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MIN.
IT WAS REPORTED THAT DURING A VITRECTOMY PROCEDURE BUBBLES ENTERED THE PATIENTS EYE FROM THE TIP OF THE VITRECTOMY CUTTER. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MIN.
IT WAS REPORTED THAT DURING A VITRECTOMY PROCEDURE BUBBLES ENTERED THE PATIENTS EYE FROM THE TIP OF THE VITRECTOMY CUTTER. NO REPORT THAT ACTUAL PATIENT HARM OCCURRED OR SURGERY WAS PROLONGED > 30 MIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1684393 | DISPOSABLE HIGH SPEED TDC CUTTER 25 G / 8000 CPM DORC CONTINUUM RANGE | OPHTHALMIC SURGICAL INSTRUMENT HANDLE, PNEUMATIC | HQC | D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. | 8268.VIT25 | 2000424133 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |