MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. PHACOEMULSIFICATION SYSTEM HANDPIECE; PHACO SURE TOUCH HANDPIECE

Catalog Number 3002.P

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 04/02/2024

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 a combined surgery, the hand-piece was not working (loss of power) properly.Therefore it was decided to replace the hand-piece before going to the fragmentation step.Efforts to replace the malfunctioning hand-piece were hindered as it was stuck and couldn't be removed from the unit.The surgery was finished by the use of a back-up unit and another phaco hand-piece.No report that actual patient harm occurred, but the surgery was prolonged > 30 minutes.

Event Description

We have been informed that during a combined surgery, the hand-piece was not working (loss of power) properly.Therefore it was decided to replace the hand-piece before going to the fragmentation step.Efforts to replace the malfunctioning hand-piece were hindered as it was stuck and couldn't be removed from the unit.The surgery was finished by the use of a back-up unit and another phaco hand-piece.No report that actual patient harm occurred, but the surgery was prolonged > 30 minutes.

Manufacturer Narrative

In regard to this complaint, one phaco suretouch phaco handpiece with serial number (b)(6) was received for investigation.Visual inspection revealed no anomalies and rigorous testing showed that the returned instrument functioned in a proper manner.Connecting handpiece on to the test equipment and eva did not cause any problems if connector is released using the release mechanism correctly.Hence, the reported compromised functionality could not be confirmed during testing.As no anomalies were found during the functional inspection, no manufacturer related cause can be attributed to this incident that would warrant the risk assessment review.No corrective actions are warranted as no manufacturer related issues were found.The analysis includes all complaints with failure mode ph-conn-stuck and ph-conn-stuck-prolonged and the sales figures of 3002.P handpieces.Since the phaco handpieces are reusable devices, the distribution figures do not reflect the total number of product on the market.Please note the amount of phaco procedures is higher than the sales figures listed.

• Brand Name: PHACOEMULSIFICATION SYSTEM HANDPIECE
• Type of Device: PHACO SURE TOUCH 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: 19115800
• MDR Text Key: 340295096
• Report Number: 1222074-2024-00011
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2024

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 Catalogue Number: 3002.P
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Type of Device Usage: Reuse
• Patient Sequence Number: 1