Model Number ED34-I10T2 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 01/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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F10 continued: international medical device regulators forum (imdrf) adverse event reporting.Health effect clinical code: 3165 device embedded in tissue or plaque.Health effect impact code: 2199 no health consequences or impact.Medical device problem code: 2907 detachment of device or device component.Component code: 424 cap.Customer did not record any of the lot numbers in any of the patient charts when this occurred.At this time they do not have traceability on the distal caps on which lot number was used.Per the account, they only have two lot numbers of sterile distal end cap model #: oe-a63 on site.Lot #: 0011112 & 0021122.D4: serial number is unknown.Pentax medical america performed a good faith effort to gather additional information regarding this event and provided an email, but has not received a response at this time.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.Importer mdr 2518897-2024-00015, dec distal cap model oe-a63, lot number 0011112 or 0021122 importer mdr 2518897-2024-00016, duodenoscope model ed34-i10t2, unknown serial number.
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Event Description
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Pentax medical was made aware of a complaint on 22-feb-2024 that occurred during treatment in the united states involving a pentax medical sterile distal end cap(dec) model oe-a63, lot number 0011112 or 0021122.The sterile single use distal cap was used with pentax medical video duodenoscope, model ed34-i10t2, unknown serial number.The customer reported that after a procedure the oe-a63 sterile distal end cap came off inside of the patient's mouth, however, they were able to retrieve the sterile distal end cap.This was not reported previously by the user facility's endoscopy technician supervisor.The exact date is unknown at this time, but customer stated it was approximately 2 months ago (december 2023).The customer also did not record any of the lot numbers in any of the patient charts when this occurred.At this time they do not have traceability on the decs lot numbers used.Per the account, they only have two lot numbers of sterile distal end cap model #: oe-a63 on site.Lot #: 0011112 & 0021122.Additionally the patient was not recalled for further screening.B3: the exact date of occurence is unknown at this time, but customer stated it was approximately 2 month ago (december 2023).Therefore, the b3 date of event was listed as 01-jan-2023.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.
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Event Description
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Refer to h11.
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Manufacturer Narrative
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Correction information
b4: date of this report
b5.Refer to h11
f7: follow up #01
f11: updated dates
f13: updated dates
additional information
d4: serial number
d4: unique identifier (udi) corrected
f9: age of device
h11: evaluation summary
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evaluation summary
pentax medical america performed a good faith effort to gather additional information regarding this event and provided an email, but had not received a response.The investigation determined that the distal end cap (dec) was not properly attached by the user and the endoscope most likely came into contact with the teeth or mouthpiece when it was taken out of the mouth, causing the dec to fall into the mouth due to the impact.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured by pentax medical miyagi on 12-nov-2021 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions, and the dates of approval for shipment and actual date shipped were confirmed on 12-nov-2021.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.Importer mdr 2518897-2024-00015, dec distal cap model oe-a63, lot number 0011112 or 0021122
importer mdr 2518897-2024-00016, duodenoscope model ed34-i10t2, serial number q111129.
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Search Alerts/Recalls
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