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

Model Number ED34-I10T2

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/21/2024

Event Type  Injury  

Event Description

Pentax medical was made aware of a complaint on (b)(6) 2024 that occurred during treatment in the united states involving a pentax medical sterile distal end cap(dec) model oe-a63, lot number 0011112 or 0021122.The sterile single use distal cap was used with pentax medical video duodenoscope, model ed34-i10t2, serial number (b)(6).The customer reported that after a procedure their patient spat out from their mouth the oe-a63 sterile distal end cap.The physician attached the oe-a63 to the ed34-i10t2 duodenoscope prior to the procedure start.However, the procedure was able to be performed to completion, without any issues during the case.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

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.Customer did not record any of the lot numbers in any of the patient charts when this occurred.At this time they do not have traceability on the distal caps on which lot number was used.Per the account, they only have two lot numbers of sterile distal end cap model #: oe-a63 on site.Lot #: 0011112 & 0021122.Therefore, the d4 lot number is listed as #: 0011112 or 0021122, two lot numbers.Pentax medical america performed good faith effort to gather additional information regarding this event and provided an email response on (b)(6) 2024 with the following information.Q1.Was the procedure for treatment or diagnostic purposes? a: treatment.Q2.Was there a delay in the procedure which would require medical intervention such as additional anesthesia or prolonged hospital stay? a: no.Q3.Was the product in question used to complete the procedure? a: yes.Q4.Please confirm if the fallen cap# oe-a63 was retrieved from the patient's body or not? a:yes.Q5.If retrieved, how did the doctor retrieve it? (using another medical device etc.) a:patient spit it out.Q6: did a nurse attach the cap# oe-a63 to the distal part of the endoscope? if so, did they hear the clicking sound when attaching it? a: doctor.Q7: how does the user consider the cause of the fallen cap# oe-a63? a: unknown.Q8: does this facility have a pentax service contract? a:expired 1/31/2024.Q9: was there a time prolongation of the procedure for retrieving the cap? no.Q10: did they receive the information and training about the proper use of cap# oe-a63? a: unknown.Q11: was the patient recalled for further screening? a: no.Q12: if no, will the patient be recalled for further screening? a:unknown.Q13: what is the current status of the patient? a:unknown.Q14: was the product removed from circulation immediately after the failure/event occurred and subsequently called in for service/replacement? a: yes.Q15: device current location and status? a: in managers office.Q16: is it possible to return the fallen retrieved cap? a: no.Q17: pre-procedural checks and use for the product involved? a: yes.Q18: reprocessing ifu? a: yes.Q19: any accessory involved ifu? a: n/a.Q20: reprocessing procedure: a: manual and automated.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.Importer mdr 2518897-2024-00009, dec distal cap model oe-a63, lot number 0011112 or 0021122 importer mdr 2518897-2024-00010, duodenoscope model ed34-i10t2, serial number (b)(6).

Event Description

Refer to h11.

Manufacturer Narrative

Correction information: b4: date of this report.B5.Refer to h11.F7: follow up #01.F11: updated dates.F13: updated dates.Additional information: d4: unique identifier (udi) corrected.F9: age of device.Evaluation summary: the investigation determined that the distal end cap (dec) was not properly attached by the user and the endoscope most likely came into contact with the teeth or mouthpiece when it was taken out of the mouth, causing the dec to fall into the mouth due to the impact.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured by pentax medical miyagi on 12-nov-2021 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-nov-2021.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.Importer mdr 2518897-2024-00009, dec distal cap model oe-a63, lot number 0011112 or 0021122 duodenoscope model ed34-i10t2, serial number (b)(6).

• Brand Name: PENTAX
• Type of Device: VIDEO DUODENO SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 18861773
• MDR Text Key: 337184762
• Report Number: 2518897-2024-00010
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04961333233007
• UDI-Public: 04961333233007
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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?: 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: 05/20/2024
• Distributor Facility Aware Date: 02/22/2024
• Device Age: 27 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other