Pentax medical was made aware of an event that occurred in the operating room during an endoscopic retrograde cholangiopancreatography(ercp) for tumor jaundice in the emea region.The user reported that a distal end cap(dec) was disconnected at the beginning of the examination in the stomach of the patient and was removed traumatically involving pentax medical accessory model oe-a63, lot number 0011050 (from ansm report), used with a pentax medical video duodenoscope, model ed34-i10t2, serial number (b)(4).The dec was withdrawn with an extraction basket with esophagus wound and the examination was stopped.The user facility reported a complaint on 20-aug-2020 in regards to pentax medical video duodenoscope, model ed34-i10t2, serial number (b)(4) for bending rubber winding on the wrong position, insertion flexible tubing(ift) worn out.Investigation in-process.
|
Per an email from pentax france on 25-aug-2020, the user facility contacted pentax on 06-aug-2020, stating that the replacement duodenoscope i10t received as a replacement is not usable due to the presence of mist on the image in regards to pentax medical video duodenoscope, model ed34-i10t2, serial number (b)(6).Investigation in-process.
|
Correction information: f7: follow up #01.F10 continued: international medical device regulators forum (imdrf) adverse event reporting.Health effect impact code: 4648 insufficient information.Component code: 424 cap.Summary: based on the investigation, the concluson was user mishandling and customer retraining was required.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.
|