BOSTON SCIENTIFIC - COSTA RICA (COYOL) DREAMTOME¿ RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00584050 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that the packaging of a dreamtome rx 44 was compromised.According to the complainant, during unpacking, the sterile packaging was found to be torn.Reportedly, there was no damage noted to the shipping box.There was no procedure involved and the device was not used in the patient.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Visual examination revealed that the pouch of the device was damaged (ruptured).The seals do not have damages.The complaint was consistent with the reported event that the seal was compromised.It is the most likely that the handle (finger ring) caused the failure noted, therefore, the most probable cause of this complaint is handling damage, since it is the most likely that the complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
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Event Description
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It was reported to boston scientific corporation that that the packaging of a dreamtome rx 44 was compromised.According to the complainant, during unpacking, the sterile packaging was found to be torn.Reportedly, there was no damage noted to the shipping box.There was no procedure involved and the device was not used in the patient.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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