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| Model Number TJF-Q180V |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that three patients were infected with escherichia coli with new delhi metallo-beta-lactamase (ndm) resistance after endoscopic retrograde cholangiopancreatography (ercp) using the olympus duodenoscope tjf-q180v serial number (b)(4).One of the three patients underwent second ercp one week later using another tjf-q180v serial number (b)(4).The infection was identified in (b)(6) 2019.Before the above event was identified, the duodenoscope was used for a patient who was a carrier of escherichia coli with ndm on (b)(6) 2019.As a result of microbiological testing by the user facility, the three samples collected from the different channels of the tjf-q180v serial number (b)(4) tested positive for escherichia coli with ndm resistance.No microbe was detected from tjf-q180v serial number (b)(4).The two tjf-q180v (s/n (b)(4) and s/n (b)(4)) were quarantined by the user facility.It was reported that the user facility had reprocessed the two tjf-q180v using unspecified endoscope reprocessing system.The user facility will return the two devices to olympus for investigation.Omsc is submitting four medical device reports according to the number of the infected patients and the number of device used for procedure.This is a report on first patient associated with tjf-q180v (s/n (b)(4)) and four of four reports.
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Manufacturer Narrative
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This supplemental report is being submitted to clarify the initial report and provide additional information.The clarification was made in reaction to the email from fda that olympus received on january 30th, 2020.Question 1: you mentioned in the reports, ¿before the above event was identified, the duodenoscope was used for a patient who was a carrier of escherichia coli with ndm on (b)(6) 2019¿.As there are two tjf-q180v duodenoscopes involved, please clarify which duodenoscope was used on the carrier of escherichia coli patient.Response of question 1: tjf-q180v serial number (b)(6) was used the carrier of escherichia coli patient.Question 2: you submitted four mdr reports (8010047-2020-01048, 8010047-2020-01049, 8010047-2020-01050, 8010047-2020-01051).For mdr 8010047-2020-01051, you stated, ¿one of the three patients underwent second ercp one week later using another tjf-q180v serial number (b)(6)¿.This is the report on first patient associated with tjf-q180v (serial number (b)(6)).Please clarify how many total patients involved in your submission of four mdrs.Was this ¿first patient associated with serial number (b)(6)¿ also one of the patients with serial number (b)(6)? response of question 2: a total of three patients was infected with escherichia coli with ndm after ercp procedures.The three patients underwent ercp procedures with the tjf-q180v serial number (b)(6) which had been used on the carrier escherichia coli with ndm.One of the three patients underwent another ercp procedure with tjf-q180v serial number (b)(6).Yes, the¿first patient associated with serial number (b)(6)¿ was also one of the three patients with the tjf-q180v serial number (b)(6) which had been used on the carrier.There is no information available so far suggesting that an olympus product may have caused/contributed to the infection of the carrier.Question 3: are there other patients exposed to the two tjf-q180v duodenoscopes involved before the scopes were quarantined? if so, how many of them? response of question 3: the available information to olympus at this moment doesn't suggest that any other patients were exposed to two the tjf-q180v duodenoscopes.Olympus will make an attempt to obtain additional information to answer this question.As a result of an attempt, olympus obtained the following information; both or either of the two tjf-q180v were used on other 19 patients between (b)(6) and the date the infection identified.The 19 patients were not infected.Olympus followed up with the user facility and received additional information as follows; the user facility conducted the microbiological testing for the tjf-q180v serial number (b)(6), escherichia coli with ndm were detected detected from the liquid samples collected from the channels of the tjf-q180v serial number (b)(6).The user facility had cleaned the two tjf-q180v using an olympus cleaning brush (bw-20t and mh-507) and reprocessed using a non-olympus automated endoscope reprocessor, wd440 (wassenburg), with a non-olympus disinfectant, cidex opa (johnson & johnson).The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc), but was returned to olympus europa se & co.Kg (oekg).Oekg sent the subject device to a third party laboratory for additional microbiological testing.As a result of the additional microbiological testing, no microbe was detected from the sample collected from the distal end unit, the forceps elevator, the instrument channel, and the air/water channel of the subject device.After additional microbiological testing, oekg evaluated the subject device and the evaluation results were as follows; the adhesive around the object lens and the light guide lens were broken.The insertion tube was buckled.The control section was discolored.The air/water cylinder, the suction cylinder, the right/left angulation control knob, and the up/down angulation lock were worn and discolored.There were corrosion in the endoscope connector, the forceps elevator, the distal end cover, and the elevator wire.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.
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Event Description
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Additional information received via literature article.Olympus reviewed the following literature titled " identification and control of two outbreaks of unrelated new delhi metallo--lactamase¿producing carbapenem-resistant escherichia coli traced to the same endoscope defect.¿ abstract: we report 2 outbreaks of genetically unrelated carbapenem-resistant new delhi metallo--lactamase¿producing escherichia coli (e.Coli ndm) caused by contaminated duodenoscopes.Using endoscopes with disposable end caps, adherence to the manufacturer¿s reprocessing instructions, routine audits, and manufacturer evaluation are critical in preventing such outbreaks.Type of adverse events/number of patients first outbreak: day 1 ¿ one patient.Sn (b)(6); day 3 ¿ one patient.Sn (b)(6); day 18 ¿ one patient.Sn (b)(6).The 3 patients underwent procedures with the same endoscopic device (endoscope 1-tjf-q180v, serial no.(b)(6)).Another endoscope was used to re-examine one of the patients (endoscope 2-tjf-q180v, serial no.(b)(6)).Both endoscopes were immediately taken out of service, and ercp procedures at the hospital were discontinued.An investigation revealed that a known e.Coli ndm carrier with e.Coli ndm detected in his gallbladder aspirate underwent ercp with the first endoscope 42 days before day 1.This patient was presumably the index case 1.Second outbreak day 203 ¿ one patient.Sn (b)(6) (this is in conflict with our records of sn (b)(6)); day 214 ¿ one patient.Sn (b)(6).On day 214, 7 months later, a rectal screening of a 2-year-old patient performed after transfer from the pediatric intensive care unit yielded a positive result for e.Coli-ndm.A rapid investigation revealed that he had undergone an ercp procedure 3 days earlier (day 211).Also, 8 days earlier (day 203), a known carrier of e.Coli-ndm (index case 2) had been treated with the same endoscope (endoscope 2-tjf-q180v, serial no.(b)(6)) (table 1).This literature article requires 6 supplemental reports.The related patient identifiers are as follows: (b)(6) : tjf-q180v, sn (b)(6) (outbreak #1, patient #1); (b)(6) : tjf-q180v, sn (b)(6) (outbreak #1, patient #2); (b)(6) : tjf-q180v, sn (b)(6) (outbreak #1, patient #3); (b)(6) : tjf-q180v, sn (b)(6) (outbreak #1, rescope, unknown patient #); (b)(6) :tjf-q180v, sn (b)(6) (outbreak #2, patient #1); (b)(6) : tjf-q180v, sn (b)(6)(outbreak #2, patient #2).This supplemental is for (b)(6).Of note, the only information reported regarding this serial number was that one of the first three patients required a rescoping for an unspecified reason.The literature article confirmed this information.No allegation of e.Coli ndm was reported or noted in the literature.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.
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Manufacturer Narrative
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This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9610595.
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Search Alerts/Recalls
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