Model Number 88-9100 |
Device Problems
Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)
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Patient Problem
Superficial (First Degree) Burn (2685)
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Event Date 08/11/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).On 16aug2021 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.
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Event Description
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Per complaint details received: multiple reusable suction electrodes are not providing cauterization and have occasional leaking.One instrument burned the surgeon's hand on (b)(6) 2021.On 24aug2021 additional information: no medical attention was needed for the surgeon.This issue of no coagulation has been going on and we are looking for a solution.No further information available.
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Event Description
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Per complaint details received: multiple reusable suction electrodes are not providing cauterization and have occasional leaking.One instrument burned the surgeon's hand on (b)(6) 2021.24aug2021 additional information: no medical attention was needed for the surgeon.This issue of no coagulation has been going on and we are looking for a solution.No further information available.
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Manufacturer Narrative
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(b)(4).Follow up: the complaint product was returned, and an evaluation was performed.The root cause of the issue is undetermined.Instrument 88-9100 batch no.G30237 indicates that the product is not a trokamed product.(the trokamed supplier code for bd is ¿xtr¿: every batch number of a trokamed product starts with this prefix).Additionally, there are some differences on a design level in comparison to our standard product mos05001.The serial number is unknown.Trokamed manufactures for bd with lot code xtr.Also, the instrument marking is black, not white as usually done by trokamed.As can be seen on the customer¿s complaint instrument, the black insulation does not extend to just before the working end, as is usual with the trokamed instrument.Perhaps the instrument was rebuilt.The product would have been manufactured and tested according to the specifications.A review of the device history records (dhr) could not be performed as the lot code is not accurate.There have been no issues identified with the material or manufacturing process.
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Search Alerts/Recalls
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