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 Date 03/02/2022

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.Based on the investigation there is no defect with the endoscope.The affected oe-a63 cap has been thrown away by the user.Another oe-a63 from the same box/lot have been tested as secure on the endoscope.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 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 physician 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 coen smits (senior product & application specialist pbnl) 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.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: 16629011
• MDR Text Key: 312142802
• Report Number: 2518897-2023-00011
• 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: 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
• 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