MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. DISPOSABLE HIGH SPEED TDC CUTTER 25 G / 8000 CPM DORC CONTINUUM RANGE; OPHTHALMIC SURGICAL INSTRUMENT HANDLE, PNEUMATIC

Catalog Number 8268.VIT25

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2022

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

The complaint is under investigation.

Event Description

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.

Manufacturer Narrative

In regard to this event, the product was recently returned for investigation.Investigation to determine the root cause of the reported event is ongoing.

Manufacturer Narrative

In regard to this complaint, one disposable high speed tdc cutter was received for investigation.Visual examination of the cutter revealed that the outer knife was slightly bent.No other anomalies were observed.Foreign material in the aspiration tube confirmed that the instrument was used.After visual inspection, the cutter was connected to a test unit.Despite rigorous testing at different cut rates with different aspiration pressure settings (50-400 mmhg), no air bubbles were detected.Device history record review revealed no deviations and a complaint database search showed that no similar complaints have been reported on this specific lot previously.Based on the investigation performed, it was concluded that the cutter met its specifications.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.

Event Description

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.

• Brand Name: DISPOSABLE HIGH SPEED TDC CUTTER 25 G / 8000 CPM DORC CONTINUUM RANGE
• Type of Device: OPHTHALMIC SURGICAL INSTRUMENT HANDLE, PNEUMATIC
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: danielle sleegers ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 13341012
• MDR Text Key: 287267794
• Report Number: 1222074-2022-00004
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8268.VIT25
• Device Lot Number: 2000425779
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1