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  

Manufacturer Narrative

H6 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.Type of investigation: 4118 type of investigation not yet determined.Investigation findings: 3233 results pending completion of investigation.Investigation conclusions: 11 conclusion not yet available.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 manufacturer reports with the fda for pentax medical video colonoscope model ec38-i10cl, serial number (b)(6).Initial patient testing positive for salmonella: manufacturer mdr 9610877-2023-00278, patient 00.Potentially contaminated endoscope cases: manufacturer mdr 9610877-2023-00279,patient (b)(6).Patient (b)(6).Manufacturer mdr 9610877-2023-00281,patient (b)(6).Manufacturer mdr 9610877-2023-00282,patient (b)(6).Manufacturer mdr 9610877-2023-00283,patient (b)(6).Manufacturer mdr 9610877-2023-00284,patient (b)(6).Manufacturer mdr 9610877-2023-00285,patient (b)(6).Manufacturer mdr 9610877-2023-00286,patient (b)(6).Manufacturer mdr 9610877-2023-00287,patient (b)(6).Manufacturer mdr 9610877-2023-00288,patient (b)(6).Manufacturer mdr 9610877-2023-00289,patient (b)(6).Manufacturer mdr 9610877-2023-00290,patient (b)(6).Manufacturer mdr 9610877-2023-00291,patient (b)(6).Manufacturer mdr 9610877-2023-00292,patient (b)(6).Manufacturer mdr 9610877-2023-00293,patient (b)(6).Manufacturer mdr 9610877-2023-00294,patient (b)(6).Manufacturer mdr 9610877-2023-00295,patient (b)(6).

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

H6 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 type of investigation: 10 testing of actual/suspected device, 3331 analysis of production records investigation findings: 4228 device incorrectly reprocessed investigation conclusions: 51 cause traced to maintenance correction information b4: date of this report g1:contact office g6: follow up #1 h2: if follow-up, what type? h3: device evaluated by manufacture h6: coding changed based on the investigation result additional information d4: unique identifier (udi) h4: device manufacture date 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 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 manufacturer reports with the fda for pentax medical video colonoscope model ec38-i10cl, serial number (b)(6).Initial patient testing positive for salmonella: manufacturer mdr 9610877-2023-00278, patient 00 potentially contaminated endoscope cases: manufacturer mdr 9610877-2023-00279,patient 01; manufacturer mdr ,patient 02; manufacturer mdr 9610877-2023-00281,patient 03; manufacturer mdr 9610877-2023-00282,patient 04; manufacturer mdr 9610877-2023-00283,patient 05; manufacturer mdr 9610877-2023-00284,patient 06; manufacturer mdr 9610877-2023-00285,patient 07; manufacturer mdr 9610877-2023-00286,patient 08; manufacturer mdr 9610877-2023-00287,patient 09; manufacturer mdr 9610877-2023-00288,patient 10; manufacturer mdr 9610877-2023-00289,patient 11; manufacturer mdr 9610877-2023-00290,patient 12; manufacturer mdr 9610877-2023-00291,patient 13; manufacturer mdr 9610877-2023-00292,patient 14; manufacturer mdr 9610877-2023-00293,patient 15; manufacturer mdr 9610877-2023-00294,patient 16; manufacturer mdr 9610877-2023-00295,patient 17.

• Brand Name: PENTAX
• Type of Device: IMAGINA COLONOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer Contact: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 18390599
• MDR Text Key: 331295057
• Report Number: 9610877-2023-00280
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04961333237869
• UDI-Public: 04961333237869
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 12/25/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other