MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER EVA

Catalog Number 8000.COM02

Device Problem Output below Specifications (3004)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

We have been informed that during procedure, there was no phaco power after priming.Using a new handpiece and reboot did not solve the problem.The phaco connector on the eva shows black spots, the phaco module is broken.The patient was on the operating table with the incisions and rhexis already made.However, the user was not able to solve the issue and it was decided to abort the surgery.The patient was transported to another site of the hospital group to continue the intervention.No report that actual patient harm occurred and it's been confirmed that the patient is doing well and no post-operative complications occurred.

Manufacturer Narrative

The complaint is under investigation.

Event Description

We have been informed that during procedure, there was no phaco power after priming.Using a new handpiece and reboot did not solve the problem.The phaco connector on the eva shows black spots, the phaco module is broken.The patient was on the operating table with the incisions and rhexis already made.However, the user was not able to solve the issue and it was decided to abort the surgery.The patient was transported to another site of the hospital group to continue the intervention.No report that actual patient harm occurred and it's been confirmed that the patient is doing well and no post-operative complications occurred.

Manufacturer Narrative

In regard to this complaint, a phacodiathermy module was provided for investigation.Investigation of this module revealed that its phaco connector was burned, due to a short circuit.Traces of liquids were observed both in the phaco connector and in the diathermy connector.Also, traces of oxidation were observed on the phacodiathermy module cover.Connecting a phaco handpiece to a wet phacodiathermy module connector will cause a short circuit.It should be noted that the instructions of the phaco handpiece indicate that all parts of the phaco handpiece should be dried after cleaning, thus prior to use.Therefore, the reported event is considered to be attributable to an unintended use error.

• Brand Name: EVA
• Type of Device: EVA
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 15976060
• MDR Text Key: 308564034
• Report Number: 1222074-2022-00090
• Device Sequence Number: 1
• Product Code: HQC
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

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: 8000.COM02
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1