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Model Number NGP680703 |
Device Problem
Mechanical Problem (1384)
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Patient Problems
Eye Injury (1845); Corneal Clouding/Hazing (1878); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/25/2023 |
Event Type
Injury
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Event Description
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It was reported that during procedure, it was unable to stop aspiration and irrigation, when the footpedal was released.It was unable to activate backflush.As a result, the anterior chamber became unstable, however, there was no posterior capsule rapture.Doctor switched the footpedal from wireless to wired mode and rebooted, however, the issue was not resolved.It got a pedal error like "it's still being pressed".Then, customer detached and reattached all equipment, tried it from the beginning, and the machine started working, and procedure was successfully completed with 60 minutes delay.Anterior vitrectomy cutter was used to treat.Additional information was received, and it was learnt that visual acuity of the patient decreased from 0.05 (pre-op) to 0.02 (post op).It was also diagnosed that patient had bullous keratopathy and decreased corneal endothelial cell.Reportedly subconjunctival injection of dexart was given for inflammation to subside.No further information provided.
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Manufacturer Narrative
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Additional narrative information: section a2: age at time of event: unknown.Section a3: date of birth and gender: unknown.Section a4: patient weight: unknown.Section a5: ethnicity and race: unknown.Section e1: telephone number: (b)(6).H-81: a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Manufacturer Narrative
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Correction data: in the initial mdr the component code was inadvertently not populated.Section h6: component code - 819 - foot pedal.Additional information: device evaluation: service was completed and product evaluation was performed for this incident.Device failed to function as intended during functional testing performed by service.Foot pedal was replaced.No product deficiency was identified.Section h6:investigational findings: 4203 - electrical/electronic component problem identified.Section h6:investigational conclusions: 4307 - cause traced to component failure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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Search Alerts/Recalls
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