JOHNSON & JOHNSON SURGICAL VISION, INC. VERITAS SWIVEL PHACO HANDPIECE SYSTEM; UNIT, PHACOFRAGMENTATION
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Model Number VRT691027 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that handpiece got clogged during surgery.Case was finished fine with ellips fx handpiece.
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Manufacturer Narrative
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Additional information: it was reported by the jnj account sales manager that the customer uses a quick rinse system to blow high pressure air thru the hand pieces.Correction: it was initially reported that the case was completed by using an ellips handpiece however, jnj was able to review video that relates to the event.The video shows that the veritas handpiece was not removed from the eye.H4 - manufacturing date - the manufacturing site reported that the manufacturing date for the device is february 24, 2021.Device evaluation: section d9 device available for evaluation? yes returned to manufacturer: yes returned to manufacturer date: august 31, 2021 section h3.Device evaluated by manufacturer? yes section h6 coding type of investigation: 10, 3331, 4109, 4110 investigation findings: 3211 investigation conclusions: 4315 device evaluation: since handpiece was not exchange this means that minimal troubleshooting was performed and so it is not possible to confirm that these were actually handpiece clogs.Microscope examination found no debris visible in the horn or lure borescope through the horn found condition was dirty but not containing any significantly sized particles.Gap area seemed same condition with no observations.Tubing area did show a kinked tube present at the region approaching the lure fitting ¿ swivel position was close to centered during approach.Swiveling the hand piece in one direction seemed able to completely close the bore.Swiveling it in the other direction was unable to eliminate the ¿kinked¿ tube.It is probable that this kinking was the cause of the clogging event on this handpiece.Device history record was reviewed and all devices meet material, assembly, and performance specifications at the time of product release.Based on the information obtained, product malfunction and product deficiency were confirmed.
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