The issue was investigated and multiple issues were identified.There was a mfg issue as the quality of the gluing process carried out at the external supplier is not satisfactory.A design issue was also identified as internal testing showed that the ring probes develop hairline fractures during sterilization process (when processed as described in the current ifu).Design may not be suitable for mfg with that amount of glue.There have not been any reported incidents regarding this issue from users of the aforementioned applicator sets / components.The gm11000280 ring probe 60 degree, 30 x 36mm is a component of the gm11000760 ring applicator, 60 degree set which is listed in the medwatch form.A corrections strategy is in progress and details will be given when finalized.
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A gm11000280 ring probe 60 degree, 30 x 36 mm (component of the gm11000760 ring applicator, 60 degree set) was taken from stock and inspected visually.It displayed a gap between the glue and the piik of the outer tube in the area where the ring channel and the outer tube are bonded together.Add' ring probes were examined and mfr defects were identified.These defects consist of gaps between the upper and lower "shell halves" of the ring probe, pin holes in the glue of the ring probe, and hairline cracks in the glue of the ring probe.Additionally, the sterilization process can cause cracks to form or widen.Due to their variable nature, these defects cannot be validated for efficacy of cleaning, disinfection and sterilization.As a result, use of the ring probes subjects users and pts to a risk of infection from a contaminated part.The gm11000290 ring probe 60 degree, 26 x 32mm and gm11000270 ring probe 60 degree, 35 x 44mm are also components of the gm11000760 ring applicator, 60 degree set and are affected by this issue.
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