MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO COLONOCOPE - I10 STANDARD

Model Number EC38-I10M

Device Problems Material Too Rigid or Stiff (1544); Defective Device (2588)

Patient Problem Erosion (1750)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

International medical device regulators forum (imdrf) adverse event reporting (b)(4).On (b)(6) 2021, a device history record(dhr) review for model ec38-i10m, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured at the (b)(4) facility on 22-jan-2018 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 for 23-jan-2018.Pentax medical engineers evaluated the endoscope at the hospital and found the endoscope was repaired with non-pentax medical components.These non-pentax parts resulted in the ift covering being too rigid or stiff, and having tight angulation and large rebound forces, potentially leading to the users experience.In addition to using third-party compenents, the user facility was actually outsourcing all the repairmen in this hospital by a third party service company.Pentax medical engineer had requested the hospital director to stop using this endoscope and suggested sending it to the pentax medical factory for service repair.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of an event that occurred in (b)(6) within the apac region.The reported event description "the newly repaired ift (insertion flexible tubing) rubber tube was too hard, resulting in partial rectal sheath film erosion after examination, without bleeding or perforation" involving the pentax medical video colonoscope model ec38-i10m, serial number (b)(4).This event occurred at the time of during use.

• Brand Name: PENTAX
• Type of Device: VIDEO COLONOCOPE - I10 STANDARD
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 13966230
• MDR Text Key: 288296496
• Report Number: 2518897-2022-00203
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EC38-I10M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2022
• Distributor Facility Aware Date: 10/16/2021
• Device Age: 44 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other