|
|
| Model Number TJF-Q190V |
| Device Problem
Microbial Contamination of Device (2303)
|
| Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 12/21/2021 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This reported event has been reported by the importer on mdr# 2951238-2022-00304.
|
| |
|
Event Description
|
|
The customer reported to olympus a patient may have an infection after an unknown procedure involving the subject device.The patient had a successful procedure (b)(6) 2021 and the next day, was admitted to the hospital with an altered state of mind.The customer reported the patient appeared septic and the origin of the infection is unknown.Attempts to gather additional information are in progress.No response to date.No additional information available.
|
| |
|
Manufacturer Narrative
|
|
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This reported event has been reported by the importer on mdr# 2951238-2022-00304.
|
| |
|
Event Description
|
|
The customer reported to olympus a patient may have an infection after an unknown procedure involving the subject device.The patient had a successful procedure (b)(6) 2021 and the next day, was admitted to the hospital with an altered state of mind.The customer reported the patient appeared septic and the origin of the infection is unknown.Attempts to gather additional information are in progress.No response to date.No additional information available.
|
| |
|
Manufacturer Narrative
|
|
This supplemental report is being submitted for additional information from the customer.New information added to a3 and b5.
|
| |
|
Event Description
|
|
Additional information was provided by the physician: the physician confirmed there was no device malfunction during the therapeutic ercp procedure with a biliary sphincterotomy and common bile duct stone extraction, performed (b)(6) 2021.The patient's admitting diagnosis was altered mental status.The physician stated the patient had a systemic inflammatory response secondary to a suspected infection following the ercp.Upon presentation, she was febrile and had a leukocytosis.She was started on antibiotics with good response.Her fever resolved greater than 24 hours prior to discharge and she is tolerating a regular diet.Oral antibiotics were initiated the day prior to discharge and she has remained stable.She will be discharged home to complete a total of 7 days of cefpodoxime and flagyl.Crp level was markedly elevated at 211.7.No clear source of infection was identified; blood cultures negative x2; urine culture>100,000 colony forming units per ml mixed flora (3 or more colony types) culture indicated contamination.The patient's medical history also includes parkinson's disease, diabetes, and hypertension.The medications the patient was taking at that time: carbidopa-levodopa (sinemet cr) 50-200 mg per cr tablet sig: take 1 tablet by mouth nightly at bedtime, carbidopa-levodopa (sinemet) 25-100 mg per tablet sig: 2 tablets 4 (four) times a day, furosemide (lasix) 20 mg tablet, sig: take 2 tablets by mouth daily patient not taking: reported on (b)(6) 2021 - losartan-hydrochlorothiazide (hyzaar) 100-25 mg per tablet sig: take half a tablet daily, polyethylene glycol (miralax) 17 gram/dose powder, sig: take 17 g by mouth daily.Patient not taking: reported on (b)(6) 2021 - pramipexole (mirapex) 0.5 mg tablet, sig: take 0.5 mg by mouth 3 (three) times a day, rasagiline (azilect) 1 mg, sig: take 1 mg by mouth daily.She is back to her baseline mental status/health.She was discharged from the hospital (b)(6) 2021.
|
| |
|
Manufacturer Narrative
|
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.On (b)(6), 2021, the olympus endoscope support specialist (ess) returned to the customer¿s site and performed a reprocessing in-service with the staff that covered the guidelines on reprocessing the olympus scopes per the on-track form and reprocessing manual.The device was returned as part of annual inspection and the following defects were identified: objective lens chipped, nozzle replaced due to damage, connecting tube slightly scratched, control section slightly scratched and universal cord slightly scratched.These defects were not considered severe enough to cause a potential adverse event and are likely due to wear and tear damage from use over an extended period of time.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the relationship between the patient infection and the device cannot be confirmed.Growth of microorganisms was found through culture testing of the patient's urine.Since olympus did not conduct additional culture testing, the device had no abnormality during the procedure, and no significant defects were found during olympus' device inspection, the root cause cannot be identified.Olympus will continue to monitor field performance for this device.
|
| |
|
Manufacturer Narrative
|
|
This supplemental report is being submitted to provide additional information received from the customer (per capa-201237 investigation activities performed by olympus).The additional information received is as follows: olympus was unable to verify the user¿s reprocessing procedure because the subject endoscope was used in a test and returned to olympus as a result.Prior to the reported event, training was provided.The training was conducted in accordance with "ontrack reprocessing in-service/customer competency for the tjf-q190v endoscope (rc7278).¿ the facility has three participants, and the staff are required to take at least one in-service training session before they can reprocess devices.There was no training conducted immediately after the reported event (outbreak).The equipment in question was a demonstration product, and the device (tjf-q190v) was purchased for the first time at the facility on 28jul2022.Device reprocessing training was conducted on 29aug2022, in conjunction with the new purchase.The training was entitled "ontrack reprocessing in-service/customer competency for evis exera iii duodenovideoscope tjf-q190v (rc8566).¿ only one subject matter expert (sme) attended the training.According to the olympus endoscopy support specialist (ess) team member in charge of the training, no deviations from the reprocessing procedure were identified during the training.It was also noted that visual checks were conducted before use of the device.It is unknown if in-hospital training was subsequently conducted.The device was delivered to the facility on 17nov2021, 34 days prior to the reported event.Annual device inspections/repairs and timeline of events are as follows: 27oct2021 - nozzle replacement repair; 17nov2021 - device delivered to facility; 21dec2021 occurrence of reported event; 05jan2022 - raise the aircraft and conduct annual inspection (a rubber adhesion part, nozzle replacement).
|
| |
|
Manufacturer Narrative
|
|
This supplemental report is being submitted to provide additional information received from the facility (per capa-201237 investigation activities performed by olympus).The additional information provided by the facility is as follows: at the time of the reported event, the olympus oer-pro endoscope reprocessor was used by the facility.The endoscopes were physically dried with a lint free cloth and stored in a ventilated cabinet.It was confirmed that the subject device involved in this reported event (distal end, bending section, etc.) was inspected (visually and functionality) both before and after the event.Per the facility, devices are sent for repair if the following criteria is met: instruction from the physicians observation or confirmed water leakage (per leakage test) visual/functionality issue per the facility¿s clinical staff, there was no confirmed infection.The patient in this case presented the day after the procedure with symptoms likely caused by anesthesia.The reported incident occurred while using the demonstration endoscope.Since, the subject device was a demonstration endoscope, it was returned to olympus the day after the procedure.Only olympus trained personnel performed reprocessing of the subject device at the time.Olympus ipc expert review: ipc cannot confirm if the infection was caused by the subject endoscope, as there was no hygiene microbiological investigation (hmi).Without hmi data, it cannot be determined if there is a relationship between the endoscope and the reported infection.Furthermore, it is known that an endoscopic retrograde cholangiopancreatography (ercp) can result in an endogenic infection.
|
| |
|
Manufacturer Narrative
|
|
This report is being submitted to correct the legal manufacturer's contact information and facility registration number.The facility registration number is 9610595.
|
| |
|
Search Alerts/Recalls
|
|
|
