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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 Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
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 2518897-2023-00058, 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
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.
 
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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, 196-0 012
JA  196-0012
MDR Report Key18382758
MDR Text Key331251264
Report Number2518897-2023-00057
Device Sequence Number1
Product Code FDF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/22/2023
Distributor Facility Aware Date12/15/2023
Event Location Hospital
Date Report to Manufacturer12/22/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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