MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO BRONCHOSCOPE

Model Number EB11-J10

Device Problem Device Reprocessing Problem (1091)

Patient Problem Bacterial Infection (1735)

Event Date 02/24/2023

Event Type  Injury  

Manufacturer Narrative

International medical device regulators forum (imdrf) adverse event reporting health effect clinical code: 1735 bacterial infection health effect impact code: 4644 medication required medical device problem code: 1091 device reprocessing problem component code: 4755 part/component/sub-assembly term not applicable in (b)(6) 2023 the affected bronchoscope eb11-j10 (sn a00kyz0032) was sent for repair to the pentax medical service center.On (b)(6) 2023, the bronchoscope was returned from repair.On (b)(6) 2023 it was sampled and microbiologically examined and there were zero(0) cfu and returned to the user facility.There was a total of eighteen(18) child patients exposed to the pentax medical bronschoscope, model eb11-j10, serial number (b)(6) since the last monitoring on (b)(6) 2023.There was a total of twelve(12) children who tested positive for pseudomonas aeruginosa infection between (b)(6) 2023 and (b)(6) 2023.The patients who tested positive received antibiotics following the results, and none returned for infectious complication.The patients will be seen by a pulmonologist with a control ecbc.There was one unrelated death describe.It is clearly stated out that the death of the patient is not related to the infectious complication.There is no causal relationship between the device and the death.After receiving the notification of these cases from the ansm, the bronchoscope was requested by pentax medical from the hospital to carry out further examinations in our service center as following.The sampling outcome after receiving the endoscope back from the hospital on (b)(6)2023 was >80 cfu/100ml which is an alert.On (b)(6) 2023 the bronchoscope was sampled and microbiologically examined.In the instrument channel there were 5 cfu and in the suction channel there were >200 cfu of pseudomonas aeruginosa.We contacted the hospital to provide us information about how they perform their re-processing of the bronchoscope eb11-j10.1a used cleaning brush: we found that the hospital uses another cleaning brush, ebi-1215 (manufactured by lta medical), instead of the recommended cleaning brush cs-c11a.This cleaning brush ebi-1215 does not fill the whole diameter of the suction channel, thus parts of the inside channel wall can be missed, resulting in not completely removing debris.1b.Drying the bronchoscope after re-processing: we were informed that the hospital manually dry the endoscope (with pressurized medical air), neither using a drying cabinet nor a drying/storage cabinet.By this means it cannot be assured that all channels are dry before entering the bronchoscope into the surestore system.If channels of the bronchoscope are not completely dry, biofilm can form and grow.In the hospital the reprocessing of bronchoscopes is almost systematically done in aer (after cleaning and rinsing step) at the centralized endoscope disinfection service or at the endoscope disinfection room located in the operating room.Manual maintenance of bronchoscopes can be done very punctually in the hospital when there is an aer failure for example.1c.Use of detergent and disinfectant although the used detergent and disinfectant are not listed on our material compatibility list for chemicals & our endoscopes, this is only related to material compatibility and not on microbiological compatibility.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.Due to this event, pentax medical filed the following mdr importer reports with the fda for pentax medical video colonoscope model eb11-j10, serial number a00kyz0032.Patient death: importer mdr 2518897-2023-00012, patient 01.Patient testing positive: importer mdr 2518897-2023-00013, patient 02.Importer mdr 2518897-2023-00014, patient 03.Importer mdr 2518897-2023-00015, patient 04.Importer mdr 2518897-2023-00016, patient 05.Importer mdr 2518897-2023-00017, patient 06.Importer mdr 2518897-2023-00019, patient 08.Importer mdr 2518897-2023-00020, patient 09.Importer mdr 2518897-2023-00021, patient 10.Importer mdr 2518897-2023-00022, patient 11.Importer mdr 2518897-2023-00023, patient 12.Patient testing negative, patient risk: importer mdr 2518897-2023-00024, patient 13.Importer mdr 2518897-2023-00025, patient 14.Importer mdr 2518897-2023-00026, patient 15.Importer mdr 2518897-2023-00027, patient 16.Importer mdr 2518897-2023-00028, patient 17.Importer mdr 2518897-2023-00029, patient 18.

Event Description

Pentax medical received an report from the french national agency for medicines and health products safety (ansm) about patient risk through a contaminated pentax medical bronschoscope, model eb11-j10, serial number (b)(6)during use within the emea region.Event description from the complaint notification form: "transmission of pseudomonas aeruginosa to patients from the endoscope.Endoscope contaminated during fibroscopy in a child with cysticovicidosis." it is clearly stated out in the ansm report, that the death of the patient is not related to the infectious complication.There is no suspection of a causal relationship between the device and the death.The date of the reported death has not been provided and remains unknown.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

Evaluation summary: it was decided to send the device to our service workshop pentax medical in bulgaria (pmb) for a repair: the device came back from pmb on (b)(6) 2023.The device was reprocessed on (b)(6) 2023.The device was sampled on (b)(6) 2023.As required by our regulation: minimum 12 hours between reprocessing and sampling the sampling outcome after the repair at our service workshop, reprocessing and renewed microbiological sampling on 6-june-2023 was < 1 cfu / 100 ml.Based on the above, it was determined that the cause was the use of an endoscope that was potentially toxic to the patient due to improper reprocessing.We suggested the customer review the manual again and gave them information on compatible brushes.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical penang on 23-jun2022 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 on 23-jun2022.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: VIDEO BRONCHOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• MDR Report Key: 16986129
• MDR Text Key: 315847927
• Report Number: 2518897-2023-00018
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EB11-J10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2023
• Distributor Facility Aware Date: 02/28/2023
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other