MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. DISPOSABLE EVA VGPC INPUT SET; ULTRASONIC SURGICAL SYSTEM TUBING SET

Catalog Number 8110.VGP01

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 06/13/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We were informed that prior to use, foreign material was noticed inside the tube.Therefore, the product was not used.No patient harm occurred.

Manufacturer Narrative

In regard to this complaint, one disposable eva vgpc input set was received for investigation.As received, the tubing had been removed from its original packaging.During thorough visual inspection, no foreign material was found in the drip chamber or in the tubing itself.Device history record review revealed, no deviations and a database search showed, that no similar complaints have been reported on this specific lot previously.Based on the investigation performed, the reported failure could not be confirmed, for the returned product.The risk identified is included in the risk management documentation.Trend analysis indicates, that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.Complaints will be closely monitored to identify any significant adverse trends.

Event Description

We were informed that prior to use, foreign material was noticed inside the tube.Therefore, the product was not used.No patient harm occurred.

• Brand Name: DISPOSABLE EVA VGPC INPUT SET
• Type of Device: ULTRASONIC SURGICAL SYSTEM TUBING SET
• 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: danielle sleegers ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 14905771
• MDR Text Key: 303921943
• Report Number: 1222074-2022-00052
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 08/09/2022

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: 8110.VGP01
• Device Lot Number: 2000428278
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/04/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1