MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. PHACO FRAGMENTATION NEEDLES, 23G / 0.6 MM, INCL. NEEDLE WRENCH; PHACOEMULSIFICATION SYSTEM HANDPIECE

Catalog Number 3005.F106

Device Problem Material Fragmentation (1261)

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

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

We have been informed that during surgery, while using the ultrasound from a 23g fragmotome through the 23g port, the surgeon noticed metal particles floating and removed them with extrusion.No report that actual patient harm occurred or surgery was prolonged > 30 min.

Manufacturer Narrative

Unfortunately, despite multiple requests, neither the involved phaco needle, nor the observed metal particles were sent to dorc for investigation.As no material was returned, physical examination to determine the origin of the particles could not be performed.Since the lot number of the phaco needle was not available, device history record review and a database search for possible similar complaints on the lot were not possible either.As the origin of the particles remains unknown and because they were only detected during the operation, the complaint cannot be attributed to the phaco needle itself or its manufacturing process.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.Since the complaint cannot be attributed to the phaco needle itself or its manufacturing process, no remedial action/corrective action/preventive action or field safety corrective action (fsca) was performed.The analysis includes complaints with failure mode ph-needle-particles and phaco needle distribution figures.

Event Description

We have been informed that during surgery, while using the ultrasound from a 23g fragmotome through the 23g port, the surgeon noticed metal particles floating and removed them with extrusion.No report that actual patient harm occurred or surgery was prolonged > 30 min.

• Brand Name: PHACO FRAGMENTATION NEEDLES, 23G / 0.6 MM, INCL. NEEDLE WRENCH
• Type of Device: PHACOEMULSIFICATION SYSTEM HANDPIECE
• 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: 16731066
• MDR Text Key: 313195698
• Report Number: 1222074-2023-00038
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3005.F106
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1