MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 2.4 MM REUSABLE PHACO SET WITH 30° STRAIGHT FLARED NEEDLE; PHACOEMULSIFICATION SYSTEM HANDPIECE

Catalog Number 3430.24SF1

Device Problem Break (1069)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.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 procedure, the needle fractured during phaco emulsification.The surgeon recovered the part that was floating in the anterior chamber and finished the surgery with a new needle.No report that patient harm occurred, or surgery was prolonged or delayed.

Event Description

We have been informed that during procedure, the needle fractured during phaco emulsification.The surgeon recovered the part that was floating in the anterior chamber and finished the surgery with a new needle.No report that patient harm occurred, or surgery was prolonged or delayed.

Manufacturer Narrative

Since the involved reusable 2.4 mm 30° straight flared phaco needle was not returned, no examination could be performed.As the manufacturing date of the reusable needle is unknown, an investigation pertinent to the manufacturing records was not possible either.Without any proper investigation, the cause of the failure remains unknown.In general, it should be noted that insufficient irrigation, and therefore insufficient cooling, is the most likely cause for the phaco needle to break during use.Since lack of irrigation may have various causes, including, but not limited to improper placement of the phaco sleeve or unfavorable settings, a main contributor the the failure could not be determined.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 a manufacturer related failure was not confirmed, no remedial action/corrective action/preventive action/field safety corrective action (fsca) was initiated.The analysis includes all complaints with failure mode as reported ph-needle-broken (rep) and, since breaking is not limited to a specific phaco needle type, the distribution figures of all phaco needles.

• Brand Name: 2.4 MM REUSABLE PHACO SET WITH 30° STRAIGHT FLARED NEEDLE
• 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: 18892399
• MDR Text Key: 337546825
• Report Number: 1222074-2024-00008
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/01/2024

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: 3430.24SF1
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1