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

Model Number ED34-I10T2

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2022

Event Type  Injury  

Manufacturer Narrative

This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Oe-a63 distal end cap disconnected from the endoscope.During the procedure the patient became unstable.While retracting the scope the oe-a63 / dec disconnected and got stuck in the throat, it's retracted with pliers and after that thrown away because it was heavily damaged.The dr and nurse assume the dec got stuck behind the bite-ring but they don't know for sure.The affected oe-a63 cap has been thrown away by the user.The other oe-a63 from the same box/lot have been tested by (b)(4) (senior product & application specialist (b)(4)) and he is absolutely sure the caps are secure on the endoscope.The remaining 3 boxes have been taken back to the office an the hospital is receiving 3 new boxes.Nobody hurt, the patient recovered.No defect with the endoscope.The time of event is during use.

Manufacturer Narrative

Correction information follow up #1, if follow-up, what type? device evaluated by manufacture coding changed based on the investigation result.Additional information: device manufacture date.Evaluation summary: it is probable that this event was caused by the user not properly attaching the oe-a63 to the endoscope.Ifu has been distributed in the past to make the installation method easier to understand.Also, there is no defect with the endoscope.The affected oe-a63 cap has been thrown away by the user.The other oe-a63 from the same box/lot have been tested as secure on the endoscope.

Manufacturer Narrative

Correction information: b1: adverse event or product problem.B2: outcomes attributed to adverse event.G2: report source.G6: follow up #2.H1:type of reportable event.H2:if follow-up, what type? h6: coding changed based on the investigation result.Evaluation summary: on march 28, 2023, while running some queries for complaint data,we found that despite the adverse event complaints when creating medwatch, malfunction checked and submitted to the fda.We submit a corrected supplemental report.

• Brand Name: PENTAX
• Type of Device: VIDEO DUODENOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 13850039
• MDR Text Key: 296868781
• Report Number: 9610877-2022-00447
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04961333233007
• UDI-Public: 04961333233007
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ED34-I10T2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other