OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; ENDOSCOPE SHEATH, REUSABLE
|
Back to Search Results |
|
Model Number A22040A |
Device Problems
Break (1069); Crack (1135)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The subject device was received and evaluated.Device evaluation found broken beak.In addition, evaluation found loose black cap and internal corrosion inside tension ring.Unrelated to the reported issue, faded label observed on the device label.Follow ups were made to gather additional information regarding the reported event , however, were unsuccessful as no response received from the customer.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
|
|
Event Description
|
As reported , the ceramic tip fell off in a patient.There was no patient harm, no user injury reported due to the event.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Three attempts were performed to obtain additional information, but no response was received from the customer.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, it is likely the broken tip occurred due to thermo-mechanical fatigue, wear and tear, and/or improper handling (impact, shock).However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿warning infection control risk: properly reprocess the product before first and each subsequent use following the instructions in this manual and in the system guide endoscopy.Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel.4.1 inspection and testing inspecting the product: visually inspect the product.Make sure that it has: no corrosion.No dents.No scratches.Ceramic insulation at distal end: visually inspect the ceramic insulation at the sheath¿s distal end before each use.Do not use the instrument in case of damage (e.G.Cracks, fractures).Warning- risk of injury: impact, fall, shock, or similar stress can damage the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries to the patient and/or user.Do not use the instrument if damaged.Damaged product: if the product is damaged or does not function properly, contact an olympus representative or an authorized service center.¿ olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|
|
|