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

Model Number ED34-I10T2

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

F10 continued: 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.Component code: 424 cap.Below is the response from the hospital after performing a good faith effort (gfe): was the procedure for treatment or diagnostic purposes?: treatment.Was either product used to complete the procedure?: no.Did a nurse attach the cap to the distal part of the endoscope?: if so, did they hear the clicking sound when attaching it? yes, she attached and heard the click.Did the duodenoscope elevator break after being removed from the patient?: no.Can you confirm the elevator broke during trouble shooting/testing?: another one same lot was tested to try to repeat the action of the first one falling off.Did the troubleshooting testing involve reattaching the dec and trying to remove it from the duodenoscope?: no.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.Importer mdr 2518897-2023-00051, dec distal end cap model oe-a63 lot number 021122 importer mdr 2518897-2023-00052, duodenoscope model ed34-i10t2 serial number (b)(6).

Event Description

Pentax medical was made aware of a complaint on 09-nov-2023 that occurred during use in canada involving a pentax medical sterile distal end cap(dec) model oe-a63, lot number 0021122.The sterile single use distal cap was used with pentax medical video duodenoscope, model ed34-i10t2, serial number (b)(6).Reassessment of the event based on good faith effort(gfe) response received from the user via email on 24-nov-2023.The customer reported that after hearing the click sound when attaching the dec to the distal end of the duodensoscope the dec had come off in the patient's mouth during treatment.Another dec, also lot number 002122, was used to continue the procedure.There was no reported harm to the patient and the patient was not recalled for further screening.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

Evaluation summary: pentax medical has requested the customer to return the complaint duodenoscope, but to date the device has not been returned for evaluation.Although the device was not returned, communications and interviews were conducted, as well as a review/analysis of the production records was performed.Additionally, the customer stated that there was no known problem with the duodenoscope.If a sterile distal end cap(dec) is not properly attached to the tip of the duodenoscope, it could result in the dec falling off if it is subjected to a load or force.However, this has not been determined in this case.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the duodenoscope was manufactured by pentax medical miyagi on 12-sep-2019 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 12-sep-2019.Based on the manufacture investigation the root cause was not able to be established.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.Importer mdr 2518897-2023-00051, dec distal end cap model oe-a63 lot number 021122 importer mdr 2518897-2023-00052, duodenoscope model ed34-i10t2 serial number a110505.

Event Description

Refer to h10.

• 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: 18242070
• MDR Text Key: 329430264
• Report Number: 2518897-2023-00052
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04961333233007
• UDI-Public: 04961333233007
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ED34-I10T2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2024
• Distributor Facility Aware Date: 11/09/2023
• Device Age: 50 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other