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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. PHACO SURE TOUCH HANDPIECE; PHACOEMULSIFICATION SYSTEM HANDPIECE
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D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. PHACO SURE TOUCH HANDPIECE; PHACOEMULSIFICATION SYSTEM HANDPIECE Back to Search Results
Catalog Number 3002.P
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problems Capsular Bag Tear (2639); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2022
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
Phaco handpiece gave no phaco power and became 'hot' on the part where the tip is screwed in.During handpiece change, congestion from the posterior segment and a capsular tear developed.Patient has compromised vision and received a sulcus lens.An additional surgery might be required.Report of prolonged surgery.User had burn marks on finger.
 
Event Description
We have been informed that during phaco procedure, the start of the surgical procedure with phaco was performed without a problem.However, it was required to use a vitrector for the anterior chamber.After successful priming, when starting the vitrectomy doesn't work, and a pop up message appeared that an incompatible pack is used.Surgery was finished without placing the iol therefor additional surgery is required.The user was not able to solve the issue and it was decided to abort the surgery.Additional surgery is required to implant the iol.
 
Manufacturer Narrative
With regards to this complaint, logfiles were provided for review.Analysis of the logfiles confirmed the occurrence of the ngui144 error, meaning that an eva 8000 vitrectome was connected to the eva nexus unit and that the eva 8000 vitrectome does not support smart iop.The error code warns the user when an eva 8000 vitrectome has been connected and the smart iop functionality is selected, because this combination is not supported.As the eva nexus system functioned as intended, this incident is considered not-reportable.Please note that instructions regarding smart iop compatible instruments, are included in eva nexus instruction manual section "7.3.3 confirming instruments for procedure".
 
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.
 
Event Description
Phaco handpiece gave no phaco power and became 'hot' on the part where the tip is screwed in.During handpiece change, congestion from the posterior segment and a capsular tear developed.Patient has compromised vision and received a sulcus lens.An additional surgery might be required.Report of prolonged surgery.User had burn marks on finger.
 
Manufacturer Narrative
In regard to this complaint, one suretouch phaco handpiece was returned for investigation.Rigorous testing revealed that the compromised functionality of the handpiece was the result of a short circuit in the transducer.The short circuit itself was most likely caused by water ingress due to a failing seal.Short circuits due to water ingress are a known issue with this product and are therefore considered an expected consequence of normal wear and tear after repeated use and reprocessing (i.E., cleaning and sterilization).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.In order to prevent this failure in relatively young handpieces such as the one involved in this case, corrective actions in terms of a more robust seal to improve resistance against water ingress are currently being implemented as part of dtp 2021-324.The analysis includes all complaints with failure mode ph-hot and ph-hot-prolonged and the sales figures of 3002.P handpieces.Please note that complaints with failure mode ph-hot are usually not reported, since the failure will not lead to serious deterioration in the satte of health of a patient.This particular case was reported due to the fact that the surgery was prolonged.Also, since the phaco handpieces are reusable devices, the sales figures do not reflect the total number of product on the market.
 
Event Description
Phaco handpiece gave no phaco power and became 'hot' on the part where the tip is screwed in.During handpiece change, congestion from the posterior segment and a capsular tear developed.Patient has compromised vision and received a sulcus lens.An additional surgery might be required.Report of prolonged surgery.User had burn marks on finger.
 
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Brand Name
PHACO SURE TOUCH HANDPIECE
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 Key16050957
MDR Text Key308483698
Report Number1222074-2022-00092
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 04/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3002.P
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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