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

Model Number EC38-I10NL

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Laceration(s) (1946)

Event Date 09/25/2023

Event Type  Injury  

Manufacturer Narrative

This device is not distributed in us so that 510k is blank.H6 continued: international medical device regulators forum (imdrf) adverse event reporting health effect clinical code: 1946 laceration(s).Health effect impact code: 4613 minor injury/ illness / impairment.Medical device problem code: 2945 free or unrestricted flow component code: 525 tube.Type of investigation: 10 testing of actual/suspected device.Investigation findings: 3233 results pending completion of investigation.Investigation conclusions: 11 conclusion not yet available.We investigated the returned endoscope and discovered that the water jet tube was clogged.Pentax medical canada performed good faith effort to gather additional information regarding this event and provided an email response on 13-oct-2023 with the following information.Was the procedure for treatment or diagnostic purposes.Diagnostic.Was the patient recalled for further screening.No.What is the current status of the patient.Patient is fine in fact, the jet was at 50, and it cut the submucosa of the patient.No puncture, but the throw was modified and different from usual.No complications for the patient.The jet was as straight and not in a circle as usual.Pre-procedural checks and use for the product involved.Yes.Reprocessing ifu.Yes.Any accessory involved ifu.No.Reprocessing procedure.Automated.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax canada inc.Was made aware of an event on (b)(6) 2023 involving a colonoscope, model ec38-i10nl, serial number (b)(6) used during a procedure on (b)(6) 2023.The customer reported that the water jet from their scope's auxiliary channel is too strong, which damages their patient's intestine during procedure.Several good faith effort attempts have been made with no response yet as of 05-oct-2023.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

International medical device regulators forum (imdrf) adverse event reporting health effect clinical code: 1946 laceration(s) health effect impact code: 4613 minor injury/ illness / impairment medical device problem code: 2945 free or unrestricted flow component code: 525 tube type of investigation: 10 testing of actual/suspected device, 3331 analysis of production records investigation findings: 180 mechanical problem identified investigation conclusions: 4307 cause traced to component failure evaluation summary: the endoscope was received on sep 28, 2023.As per the inspection, it was found that the auxiliary/forward water jet channel was clogged.Based on the reported content, it was determined that the cause of intestinal mucosal damage was that the cross-sectional area of the water jet channel was reduced due to clogging, which accelerated the flow velocity.The forward water jet was cleaned properly by the expert technician and as per the manufacturer's repair procedure.Upon cleaning, all quality tests were completed and passed.The scope was returned on oct 2, 2023.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 17-apr-2020 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 17-apr-2020.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 COLONO SCOPE
• 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 ; 2015712340
• MDR Report Key: 17937046
• MDR Text Key: 325678882
• Report Number: 9610877-2023-00235
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC38-I10NL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other