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 01/01/2023

Event Type  Injury  

Manufacturer Narrative

H6 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: 4604 delay to treatment/ therapy, 4641 unexpected medical intervention medical device problem code: 2907 detachment of device or device component component code: 424 cap type of investigation: 4118 type of investigation not yet determined investigation findings: 3233 results pending completion of investigation investigation conclusions: 11 conclusion not yet available.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.D4: serial # is unknown.Pentax medical america performed good faith effort to gather additional information regarding this event and provided an email response on 04-mar-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: no q4: if no, was a different or similar product used to complete the procedure? a: unknown.Q5.Please confirm if the fallen cap# oe-a63 was retrieved from the patient's body or not? a: it was.Q6.If retrieved, how did the doctor retrieve it? (using another medical device etc.) a:they had to stop the procedure, in order to retrieve the oe-a63 sterile distal end cap.Q7: 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 attached the oe-a63.Unknown at this time if he heard the click.Q8: how does the user consider the cause of the fallen cap# oe-a63? a: faulty equipment.Q9: does this facility have a pentax service contract? a:expired 1/31/2024 q10: was there a time prolongation of the procedure for retrieving the cap? no q11: did they receive the information and training about the proper use of cap# oe-a63? a: ifu s277-r01 was used for training and the hear the click training.Q12: was the patient recalled for further screening? a: no q13: if no, will the patient be recalled for further screening? a:unknown q14: what is the current status of the patient? a:unknown q15: was the product removed from circulation immediately after the failure/event occurred and subsequently called in for service/replacement? a: yes q16: device current location and status? a: customer site q17: is it possible to return the fallen retrieved cap? a: unknown q18: pre-procedural checks and use for the product involved? a: yes q19: reprocessing ifu? a: yes q20: any accessory involved ifu? a: n/a q21: 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.Manufacturer mdr 9610877-2024-00022, dec distal cap model oe-a63 lot number 0011112 or 0021122.Manufacturer mdr 9610877-2024-00023, duodenoscope model ed34-i10t2 serial number unknown.

Event Description

Pentax medical was made aware of a complaint on 22-feb-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, unknown serial number.The customer reported that during a procedure the oe-a63 sterile distal end cap fell off into the patient's stomach.They had to stop the procedure, in order to retrieve the oe-a63 sterile distal end cap.There was no reported harm to the patient and the patient was not recalled for further screening.B3: the exact date of occurence is unknown at this time, but customer stated it was approximately 6 months ago ((b)(6) 2023).Therefore, the b3 date of event was listed as 01-jan-2023.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

H6 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: 4604 delay to treatment/ therapy, 4641 unexpected medical intervention medical device problem code: 2907 detachment of device or device component component code: 424 cap type of investigation: 4111 communication/interviews investigation findings: 114 operational problem identified investigation conclusions: 19 cause traced to user correction information b4: date of this report h2:if follow-up, what type? h3:device evaluated by manufacture h6: coding changed based on the investigation result additional information d4:serial number d4:unique identifier (udi) h4:device manufacture date h11: evaluation summary 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 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.Manufacturer mdr 9610877-2024-00022, dec distal cap model oe-a63 lot number 0011112 or 0021122 manufacturer mdr 9610877-2024-00023, duodenoscope model ed34-i10t2 serial number q111129.

• Brand Name: PENTAX
• Type of Device: VIDEO DUODENO SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer Contact: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 18872282
• MDR Text Key: 337293103
• Report Number: 9610877-2024-00023
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04961333233007
• UDI-Public: 04961333233007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/10/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention