Model Number SEEG DRILL ADAPTOR 2.45MM |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.Unique identifier (udi) #: unknown.
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Event Description
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Company clinical representative (cr) received a phone call from the rosa advance user at (b)(6) hospital.She stated that the following complaint events happened during a seeg surgery: the surgeon says that he was having trouble with two new 2.45 mm drill adaptors.The pmt anchor bolt for the seeg electrodes and the standard 2.4 mm drill bit they normally use goes through these adaptors fine.However, the pmt anchor bolt driver could not fit through the adaptors.According to the advance user, the surgeon was only able to have the distal tip of the anchor bolt driver partially enter the adaptor but not completely go through it.Afterwards, the hospital staff members went and got the rosa tray with their old 2.45 mm drill adaptors to use and it worked fine.The delay for this complaint event was approximately 10 minutes.
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Manufacturer Narrative
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Corrected data: - b4 date of this report - d10 device availability - g4 date received by manufacturer - h2 if follow-up, what type - h10 additional narratives/data.
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Event Description
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Company clinical representative (cr) received a phone call from the rosa advance user at (b)(6) hospital.She stated that the following complaint events happened during a seeg surgery: the surgeon says that he was having trouble with two new 2.45 mm drill adaptors.The pmt anchor bolt for the seeg electrodes and the standard 2.4 mm drill bit they normally use goes through these adaptors fine.However, the pmt anchor bolt driver could not fit through the adaptors.According to the advance user, the surgeon was only able to have the distal tip of the anchor bolt driver partially enter the adaptor but not completely go through it.Afterwards, the hospital staff members went and got the rosa tray with their old 2.45 mm drill adaptors to use and it worked fine.The delay for this complaint event was approximately 10 minutes.
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Manufacturer Narrative
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It was reported that the pmt anchor bolt driver could not fit through the drill adaptors, the user was only able to have the distal tip of the anchor bolt driver partially enter but not completely go through it.The subject drill adaptors, sn (b)(6) and s/n (b)(6) , were returned at the manufacturing site for investigation.A visual inspection did not indicate any external visible damage that could have caused or contributed to the event.No further analysis was performed on the returned part as the reported event is assessed to be linked to an existing capa.The investigation performed through this capa concluded that the drill adaptor design must be improved.D4 unique identifier (udi) #: (b)(4).
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Event Description
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Company clinical representative (cr) received a phone call from the (b)(4) user at (b)(6) hospital.She stated that the following complaint events happened during a seeg surgery: the surgeon says that he was having trouble with two new 2.45 mm drill adaptors.The pmt anchor bolt for the seeg electrodes and the standard 2.4 mm drill bit they normally use goes through these adaptors fine.However, the pmt anchor bolt driver could not fit through the adaptors.According to the advance user, the surgeon was only able to have the distal tip of the anchor bolt driver partially enter the adaptor but not completely go through it.Afterwards, the hospital staff members went and got the rosa tray with their old 2.45 mm drill adaptors to use and it worked fine.The delay for this complaint event was approximately 10 minutes.
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Search Alerts/Recalls
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