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

Catalog Number 3002.P

Device Problem Output below Specifications (3004)

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

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.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 phaco surgery, the ultrasound function suddenly fails when the super breast handle is used, and the body of the super breast handle is too hot to use.The surgery was completed with another pack of the same type.Surgery was prolonged > 30 min.No report that actual patient harm occurred.

Event Description

We have been informed that during phaco surgery, the ultrasound function suddenly fails when the suretouch handle is used, and the body of the suretouch handle is too hot to use.The surgery was completed with another pack of the same type.Surgery was prolonged > 30 min.No report that actual patient harm occurred.We have been informed that in hindsight, the event did not occur during surgery; no prolonged surgery took place.Therefore, the incident is assessed as not reportable.

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); however, 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 have been implemented.We have been informed that in hindsight, the event did not occur during surgery and therefor surgery was not prolonged.Therefore, the incident is assessed as not reportable.We have been informed that in hindsight, the event did not occur during surgery and therefor surgery was not prolonged.Therefore, the incident is assessed as not reportable.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 were implemented as part of dtp 2021-324.

• 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 Key: 17780393
• MDR Text Key: 323826249
• Report Number: 1222074-2023-00065
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/15/2023

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: 3002.P
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1