MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. SHIELDED TOTALVIEW ENDOILLUMINATION PROBE, INCLUDING ILLUMINATED SCLERAL DEPRESS; OPHTHALMIC FIBREOPTIC-LIGHT INSTRUMENT, SINGLE-USE

Catalog Number 3269.SBS05

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/10/2023

Event Type  malfunction  

Event Description

We have been informed that prior to surgery, it was noticed that there was foreign material in the package.Therefore, the product was not used.No patient harm occurred.

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.

Manufacturer Narrative

In regard to this complaint, an unopened peel pouch including a plastic bag with a 25 gauge shielded totalview endo-illumination probe was received for investigation.Visual inspection of the returned product confirmed the presence of foreign material in the packaging.Further examination, showed that the material was in fact an artifact in the plastic of the bag that held the probe.No further anomalies were observed.Unfortunately, the origin of the artifact could not be determined since the plastic bags are purchased from an external supplier.Despite control measures in place, the artifact was not detected before the product was released for distribution.A database search showed that no similar complaints have been reported on this specific issue previously.Based on the investigation performed, it is determined that the reported event is attributable to an human error during quality control.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.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 light probes both sold as individual products and as part of procedure packs are included in the analysis.Distribution figures up to (b)(6) 23 are reflected.

Event Description

We have been informed that prior to surgery, it was noticed that there was foreign material in the package.Therefore, the product was not used.No patient harm occurred.

• Brand Name: SHIELDED TOTALVIEW ENDOILLUMINATION PROBE, INCLUDING ILLUMINATED SCLERAL DEPRESS
• Type of Device: OPHTHALMIC FIBREOPTIC-LIGHT INSTRUMENT, SINGLE-USE
• 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: 16672088
• MDR Text Key: 312804796
• Report Number: 1222074-2023-00034
• 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: 3269.SBS05
• Device Lot Number: 2000422085
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1