MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. OPHTHALMIC LASER SYSTEM BEAM GUIDE; DIRECTIONAL LASER PROBE WITH DORC CONNECTOR.(25 GAUGE / 0.5 MM)

Catalog Number 7225.DORC

Device Problem Break (1069)

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

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.As investigations on the actual product or representative sample of a batch may alter the device, we request to inform us within 7 days after submission of this report, in case the investigations that alter the device should be halted until approval of the nca, as per article 89 of eu-mdr.

Event Description

We have been informed that during surgery, the metal part which contains the laser fiber is separated from the plastic handle.As a result, it is no longer possible to direct the laser into the eye.The surgery was continued using another laser probe.No report that actual patient harm occurred or surgery was prolonged > 30 min.

Manufacturer Narrative

In regard to this complaint, one 25-gauge straight laser probe with a dorc connector was received for investigation.Upon receipt, the glue connection between the 1.2 mm filler capillary and the handle appeared to be compromised.Glue residue was observed.Further visual inspection showed that the blue control knob was cracked.The break compromised the connection between the knob and the 0.9 mm capillary on the inside of the handpiece.Device history record review revealed no deviations, and a database search showed that no similar complaints have been reported on this specific lot prior to this case or since.Based on the investigation performed, manufacturer related failures could not in fact be confirmed; however, though severe manipulation may very well be the cause for the compromised connections, a deficiency to the knob (e.G.Injection molding defect) and an initially inferior glue connection between the filler capillary and the handle cannot be ruled out completely.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.Since the investigation findings did not lead to a clear conclusion about the cause of the reported adverse event, no remedial,preventive or (field safety) corrective actions were taken.The analysis includes all complaints with failure mode la-shaft-loose and the sales figures for directional laser probes.Though the complaint numbers for 2023 are complete, the sales figures have last been updated at the end of may.Hence, the number of directional laser probes that reached the market was in fact higher than reflected in the above table.

Event Description

We have been informed that during surgery, the metal part which contains the laser fiber is separated from the plastic handle.As a result, it is no longer possible to direct the laser into the eye.The surgery was continued using another laser probe.No report that actual patient harm occurred or surgery was prolonged > 30 min.

• Brand Name: OPHTHALMIC LASER SYSTEM BEAM GUIDE
• Type of Device: DIRECTIONAL LASER PROBE WITH DORC CONNECTOR.(25 GAUGE / 0.5 MM)
• 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: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 17773359
• MDR Text Key: 323724664
• Report Number: 1222074-2023-00064
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7225.DORC
• Device Lot Number: 2502-*-*-1
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1