ETHICON ENDO-SURGERY, LLC. DEXTRUS SEAL CAP ASSEMBLY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number HAP02 |
Device Problem
Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.As a lot/batch was not provided, a device history could not be performed.Additional information was requested and the following was obtained: what part of the device was torn, the iris value seal or the retractor sheath? did any pieces of the device fall into the patient? if yes, how were the pieces retrieved? was there any loss of pneumo due to the tear in the device? how was the procedure completed? was there any patient consequence? response: no further information available.
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Event Description
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Pulled it lightly, but tear.There were no patient consequences.
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Manufacturer Narrative
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(b)(4).Batch # p93m0t.Device analysis: the analysis results found that an hap02 device was returned with no damage in the external components.The device was visually inspected and no anomalies were noted; was tested for functionality and work as intended.As the device was found to be fully functional, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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