MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA COLONOSCOPE

Model Number EC38-I10CL

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

As part of a good faith effort follow up response received via email on 15-dec-2023 pentax medical became aware of 17 patients cases with potential exposed to salmonella involving pentax medical video colonoscope model ec38-i10cl, serial number (b)(6).The original patient was seen for a colonoscopy diagnostic procedure for suspected colitis.The procedure was completed successfully with no reported delay.The patient was discharged that day.The following day, the patient self-elected to go to the emergency room for continual pain.The patient had surgery and received a diagnosis of salmonella.The endoscope that was used to perform the patient's colonoscopy was reprocessed with hld(high-level disinfection) per the facility's cleaning protocols which follow our pentax medical instructions for use(ifu).The endoscope was also used on 17 patients before the user facility's infection control was informed of the patient's subsequent salmonella diagnosis.Infection control decided to culture and quarantine the endoscope and received a positive salmonella culture back, even though the endoscope had been used and reprocessed with hld 17 times since the original colonoscopy.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

F10 continued: international medical device regulators forum (imdrf) adverse event reporting health effect clinical code: 4582 no clinical signs, symptoms or conditions.Health effect impact code: 4648 insufficient information.Medical device problem code: 2303 microbial contamination of device.Component code: 4755 part/component/sub-assembly term not applicable.Investigation is in-process.Although the cases occurred in december 2023, the exact event date has not been provided for either the initial patient case, or the additional 17 patient cases.On 21-dec-2023 pentax medical clinical communicated to the complaint handling team via teams that for the user testing, salmonella - no species data identification, was performed.Additionally clinical confirmed the awareness date for the 17 additional patient cases as 15-dec-2023, with only the original patient being confirmed with salmonella.The loaner endoscope, pentax medical video colonoscope model ec38-i10cl, serial number (b)(6) was received by pentax medical for evaluation on 15-dec-2023 under maintenance request (b)(4).The endoscope will be sampled prior to reprocessing, and then again after reprocessing, under work order (b)(4).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 ec38-i10cl, serial number (b)(6).Initial patient testing positive for salmonella: importer mdr 2518897-2023-00054, patient 00.Potentially contaminated endoscope cases: importer mdr 2518897-2023-00055, patient 01, importer mdr 2518897-2023-00056, patient 02, importer mdr 2518897-2023-00057, patient 03, importer mdr 2518897-2023-00058, patient 04, importer mdr 2518897-2023-00059, patient 05, importer mdr 2518897-2023-00060, patient 06, importer mdr 2518897-2023-00061, patient 07, importer mdr 2518897-2023-00062, patient 08, importer mdr 2518897-2023-00063, patient 09, importer mdr 2518897-2023-00064, patient 10, importer mdr 2518897-2023-00065, patient 11, importer mdr 2518897-2023-00067, patient 13, importer mdr 2518897-2023-00068, patient 14, importer mdr 2518897-2023-00069, patient 15, importer mdr 2518897-2023-00070, patient 16, importer mdr 2518897-2023-00071, patient 17.

Manufacturer Narrative

Evaluation summary.Pentax medical was unable to obtain information on harm for the remaining 17 patients.Resampling of the endoscope, even before reprocessing, showed no presence of salmonella again.However, some other moderate / low concern micro-organisms were detected, even after reprocessing.The post-reprocessing micro-organisms were most likely introduced during the sampling process.Borescope inspection showed some scratches inside the operation channel, with the most severe scratches around 40cm marking of the insertion tube.On some pictures plastic pieces cut out of the channel can be seen.The origin of these is unknown but could be possibly related to passing instruments in an improper way through the channels.Besides the indicated scratches no abnormalities could be seen.Scratches can be niches for soil and dirt, and microorganisms, and this may be difficult to remove during cleaning stages of the channel such as brushing.In this, it is not clear whether these scratches could be harboring biofilm and / or salmonella or not, and if this could be a failure in removing dirt, soil and bacteria.The reprocessing steps seems adequate, and the used high-level disinfectant should be capable to kill even salmonella.But again, if there is a biofilm, this can be the reason for surviving bacteria, resulting in a positive sample.Looking at this case, an endoscope was possibly contaminated during clinical use on a patient with a proven salmonella carrier or infection stage.After the finding, the endoscope was used on 17 other patients and reprocessed again 17 times.Resampling afterwards didn't show the presence of salmonella anymore, meaning frequent reprocessing has possibly led to elimination of this bacteria from the operation channel.The operation channel showed some scratches, but a correlation between these and the finding of salmonella is difficult, as the scratches could also be caused after use on the index patient (during some of the other 17 uses of the endoscope).Based on all available information, we may conclude the endoscope itself is not the primary problem of this contamination, but that it most likely concerns failure modes in the reprocessing, esp.The manual precleaning of the endoscope.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured by pentax medical miyagi on 22-may-2022 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 22-may-2022.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.Due to this event, pentax medical filed the following mdr importer reports with the fda for pentax medical video colonoscope model ec38-i10cl, serial number (b)(6).Initial patient testing positive for salmonella: importer mdr 2518897-2023-00054, patient 00 potentially contaminated endoscope cases: importer mdr 2518897-2023-00055, patient 01.Importer mdr 2518897-2023-00056, patient 02.Importer mdr 2518897-2023-00057, patient 03.Importer mdr 2518897-2023-00058, patient 04.Importer mdr 2518897-2023-00059, patient 05.Importer mdr 2518897-2023-00060, patient 06.Importer mdr 2518897-2023-00061, patient 07.Importer mdr 2518897-2023-00062, patient 08.Importer mdr 2518897-2023-00063, patient 09.Importer mdr 2518897-2023-00064, patient 10.Importer mdr 2518897-2023-00065, patient 11.Importer mdr 2518897-2023-00066, patient 12.Importer mdr 2518897-2023-00067, patient 13.Importer mdr 2518897-2023-00068, patient 14.Importer mdr 2518897-2023-00069, patient 15.Importer mdr 2518897-2023-00070, patient 16.Importer mdr 2518897-2023-00071, patient 17.

Event Description

Refer to h10.

• Brand Name: PENTAX
• Type of Device: IMAGINA COLONOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• MDR Report Key: 18382765
• MDR Text Key: 331252375
• Report Number: 2518897-2023-00066
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC38-I10CL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2024
• Distributor Facility Aware Date: 12/15/2023
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other