MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. DISPOSABLE EVA DRAPES; SYSTEM ACCESSORIES

Catalog Number 8110.DRA01

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/08/2023

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.

Event Description

We were informed that foreign material was noticed in the packaging.The product has not been used.No patient harm occurred.

Manufacturer Narrative

In regard to this complaint, an opened peel pouch including disposable eva drapes was received for investigation.Visual inspection of the returned product confirmed the presence of a hair-like fiber in the pouch.Device history record review revealed no deviations and a database search showed that no similar complaints have been reported prior to this case or since.Since the pouch was already opened on receipt, we cannot determine with certainty whether or not the hair was present before the pouch was sealed.Please note that our operations are executed in a class 7 clean room environment to ensure minimum contamination and that the products are subject to 100% visual inspection before the product is released for distribution.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.All similar incidents related to disposable eva drapes are included in the analysis.Distribution figures up to 25apr23 are reflected.

Event Description

We were informed that foreign material was noticed in the packaging.The product has not been used.No patient harm occurred.

• Brand Name: DISPOSABLE EVA DRAPES
• Type of Device: SYSTEM ACCESSORIES
• 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: 16672180
• MDR Text Key: 312594518
• Report Number: 1222074-2023-00035
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8110.DRA01
• Device Lot Number: 2000436356
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1