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U.S. Department of Health and Human Services

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

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; IMAGINA COLONOSCOPE Back to Search Results
Model Number EC38-I10CL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
H6 continued: international medical device regulators forum (imdrf) adverse event reporting health effect clinical code: 1735 bacterial infection.Health effect impact code: 4607 hospitalization or prolonged hospitalization, 4625 additional surgery.Medical device problem code: 2993 adverse event without identified device or use problem.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.A good faith effort response was received via email on 15-dec-2023 with the following additional information.The 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.Although the cases occurred in (b)(6) 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 (b)(6) 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, patient (b)(6).Potentially contaminated endoscope cases: manufacturer mdr 9610877-2023-00279,patient 01, manufacturer mdr 9610877-2023-00280,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.
 
Event Description
Pentax medical was made aware of an adverse event on 14-dec-2023 that occurred in the united states involving pentax.Medical video colonoscope model ec38-i10cl, serial number (b)(6).The customer initially reported the patient presented in the er[emergency room] with pain, and would later test positive for salmonella.The patient medical history was not provided.There was no known product malfunction reported.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.
 
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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
william goeller
3 paragon drive
montvale, NJ 07645
8004315880
MDR Report Key18390595
MDR Text Key331283766
Report Number9610877-2023-00278
Device Sequence Number1
Product Code FDF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190805
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/25/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberEC38-I10CL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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