D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. SHIELDED TOTALVIEW ENDOILLUMINATION PROBE, INCLUDING ILLUMINATED SCLERAL DEPRESS; OPHTHALMIC FIBREOPTIC-LIGHT INSTRUMENT, SINGLE-USE
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Catalog Number 3269.SBS05 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2023 |
Event Type
malfunction
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Event Description
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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.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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.
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Event Description
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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.
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Search Alerts/Recalls
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