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 Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

International medical device regulators forum (imdrf) adverse event reporting: health effect clinical code: 3165 device embedded in tissue or plaque; health effect impact code: 2199 no health consequences or impact; medical device problem code: 2907 detachment of device or device component, 4014 device fell, component code: 424 cap.On 08-nov-2021, the associated complaint was initially assessed as a reportable malfunction and not reported to the fda by the importer.On 28-mar-2023, the us_decision tree was reassessed by the manufacturer and the complaint was determined to be a reportable serious injury based on the available information and the importer was notified.The endoscope has been inspected with the oe-a63 cap that fell off in the patient.It was put on several times and checked by pulling lightly, whether it was securely in place, without any complaints and it has been tested also with some brand new caps several times.There was no problem with the installation, nor this the disconnection from the endoscope.There is no damage or failure with the endoscope or with the oe-a63.Based on the investigation there is no observed defect with the endoscope or the caps.The users will be retrained and the complaint is closed as fixed.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

Event Description

Pentax medical was made aware of a complaint that occurred in the operating room during use in the emea region involving pentax medical video duodenoscope model ed34-i10t2, serial number (b)(4).The reported complaint that the pentax medical sterile distal end cap accessory, model oe-a63, lot number 0011061 fell off during the examination and had to be recovered.Nobody has been harmed.Pentax medical asked service for inspection of the endoscope and the caps.Independent from the investigation, we strongly recommend to re-train the users at the hospital on how to attach the oe-a63 and check its operational condition properly, of course with reference to the recent fsca & updated ifu.Event date is unknown, however it was submitted to the manufacturer in 2021.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.

• 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
• MDR Report Key: 16628830
• MDR Text Key: 312142326
• Report Number: 2518897-2023-00010
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04961333233007
• UDI-Public: 04961333233007
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2023
• Distributor Facility Aware Date: 03/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other