Model Number EG-3890TK |
Device Problem
Mechanical Problem (1384)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The loaner endoscope will be evaluated by pentax medical.Once evaluation is completed the device will be repaired and put back into loaner inventory.Model eg-3890tk, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.On 01-feb-2022, a device history record(dhr) review for model eg-3890tk, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the miyagi facility on 23-aug-2011 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 for 23-aug-2011.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.
|
|
Event Description
|
Pentax medical was made aware of a complaint that occurred in the (b)(6).The customer reported right/left angulation broken involving pentax medical video gastroscope, model eg-3890tk, serial number (b)(4).The event timing and location are unknown.No death or serious injury was reported.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.
|
|
Manufacturer Narrative
|
Correction information: h6: coding changed, based on the investigation result.Evaluation summary: it seems to be a complaint, that the angle operation became impossible, but the cause could not be determined.The cause is assumed to be elongation or breakage of the wire.
|
|
Search Alerts/Recalls
|
|