MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; STERILE DISTAL END CAP WITH ELEVATOR

Model Number OE-A63

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/24/2023

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: 2199 no health consequences or impact 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 pentax medical pai received a good faith effort(gfe) response by e-mail on (b)(6)2023.Details below.Who was involved (clinician, technician, patient, other) - clinician and patient.What procedure was involved- ercp.Was the procedure for treatment or diagnostic purposes-treatment was there any risk or potential cross contamination to other patients- 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.- according to the customer yes, but they do not know for sure.How does the user consider the cause of the fallen cap.- they aren't sure if it's user error or a product error was there a time prolongation of the procedure for retrieving the cap?- yes in 2021, "fsca-pmj-21-04_ed34-i10t2 ifu replacement" was conducted in the us.By any chance was this facility included in the affected sites.If so, did they receive the information and training about proper use.- yes.The facility was trained however staff turn over is high and the particular staff who attached, we are unsure if they received the training.Additional training is happening next week for customer.What is the current status of the patient.- no issues when was it first observed- aug 24, 2023.Where in the facility did it happen- endoscopy.Where was it first observed- in the procedure room.How did it happen (if known):-possibly improper training to new users.If additional information becomes available, a supplemental report will be filed with the new information.Manufacturer mdr 9610877-2023-00224, dec distal cap model oe-a63 lot number 0011112, 24-aug-2023 procedure manufacturer mdr 9610877-2023-00225, duodenoscope model ed34-i10t2 serial number (b)(6), 24-aug-2023 procedure.

Event Description

Pentax medical was made aware of a complaint on(b)(6) 2023 that occurred in the operating room during use in canada on (b)(6) 2023.Per the initial report, a clinician was starting an ercp[endoscopic retrograde cholangiopancreatography] and the sterile single use distal end cap(dec), model oe-a63, lot number 0011112, fell off the duodenoscope occluding the airway.As a result, the procedure was stopped and the patient coughed out the cap[dec].The sterile single use distal end cap was used with pentax medical video duodenoscope model ed34-i10t2, serial number (b)(6).The dec has been discarded but the duodenoscope is expected for return and evaluation.The patient was not recalled for further screening and no patient issues were reported.Although no harm was reported to the patient, since the distal end cap detached from the duodenoscope inside the patient and required the procedure to be discontinued and also allow the patient to cough out the sterile single use distal end cap we will be reporting this event as fda-reportable."yes" was selected for question "3.6 other serious(important medical events)" since the procedure was discontinued and the event was resolved by the patient needing to cough out the distal end cap.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: 2199 no health consequences or impact.Medical device problem code: 2907 detachment of device or device componen.Component code: 424 cap.Type of investigation: 3331 analysis of production records.Investigation findings: 4248 usage problem identified.Investigation conclusions: 27 cause traced to training, 19 cause traced to user evaluation summary: pentax medical requested a return of the affected duodenoscope and the involved oe-a63 distal end cap(dec) in this incident.The dec was disposed of so evaluation was not possible.The duodenoscope was returned to pentax canada on 06-sep-2023 and evaluated on 13-sep-2023.The duodenoscope passed all functional testing during inspection.During the evaluation, a crack in the lcb cover glass on the distal end was noticed.Also a minor adjustment in the elevator mechanism was required, but did neither observation affected the function of the dec attachment.Additionally, since the duodenoscope distal end diameter and other specifications were within the manufacturer's recommendation, pci was able to test another oe-a63 dec and it was connecting and disconnecting fine.The user facility also reported that retraining was needed within the clinical team for proper attachment and use of oe-a63 decs.The dhr review confirmed the endoscope was manufactured on 24-oct-2022 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 on 04-nov-2022 and actual date shipped were confirmed on 07-nov-2022.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.Manufacturer mdr 9610877-2023-00224, dec distal cap model oe-a63 lot number 0011112, 24-aug-2023 procedure.Manufacturer mdr 9610877-2023-00225, duodenoscope model ed34-i10t2 serial number (b)(6) , 24-aug-2023 procedure.

• Brand Name: PENTAX
• Type of Device: STERILE DISTAL END CAP WITH ELEVATOR
• 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: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 17770391
• MDR Text Key: 323681464
• Report Number: 9610877-2023-00224
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K192245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OE-A63
• Device Lot Number: 0011112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male