INTEGRA LIFESCIENCES CORPORATION OH/USA MAYO SWIVEL RETRACTOR, 2.75; SURGICAL RETRACTOR
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Catalog Number 3335 |
Device Problem
Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The omni-clamp sterile field post (3555) was returned to integra service and repair for evaluation: failure analysis: evaluation of the mayo swivel retractor found that the.375 clamp was damaged, and some small parts were worn.The clamp and small parts were renewed.The unit was tagged with an instance number and function test was carried out.Root cause analysis: based on evaluation by integra service and repair, the clamp was found to be damaged, likely causing the alleged issue of the clamp not being able to be fixed to the metal rod of the blade, and thus damaging the retractor in the process.This damage was most likely caused by either a lack of proper care for the product to prevent damages, or simply accidental damaging of the product.No further investigation required based on the acceptability of risk.This issue and similar events are monitored and trended.
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Event Description
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This is 3 of 4 reports, linked to mfg numbers: 3004608878-2022-00033, 3004608878-2022-00035, 3004608878-2022-00037.A facility reported that during and after a procedure, the omni-clamp sterile field post,.75 x.50 (3555) was damaged due to a defective clamp.It was reported that the procedure was finished in an "old-school" way of having the intern hold some hooks and retractors.The device was in contact with the patient.It was reported that the event led to an increase in surgery time of ¿around 30 minutes¿; however, no patient injury or death occurred.
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Manufacturer Narrative
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Updated b4: a facility reported that during and after a procedure, the mayo swivel retractor (3335) was damaged due to a defective clamp.It was reported that the procedure was finished in an "old-school" way of having the intern hold some hooks and retractors.The device was in contact with the patient.It was reported that the event led to an increase in surgery time of ¿around 30 minutes¿; however, no patient injury or death occurred.Corrected h10: the evaluation results reported on initial mdr was incorrectly documented for this product.The following below replaces previous evaluation results: the mayo swivel retractor (3335) was later returned for failure analysis: failure analysis of the retractor noted minor cosmetic scratches on the proximal end of the retractor rod, where the rod is inserted to the frame clamp.The retractor blades functioned as intended without issue or defect.Root cause analysis found incidental scratches (cosmetic) at the proximal end of the retractor connection rod were verified, most likely caused by improper attachment to the snap clamp assembly or omni-tract frame.No further investigation is required based on the acceptability of risk.At present, we consider this complaint to be closed.
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Event Description
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N/a.
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Search Alerts/Recalls
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