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 11/09/2023

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.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.Manufacturer mdr dec distal cap model oe-a63 lot number 021122 manufacturer mdr 9610877-2023-00273, 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

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 code: 424 cap type of investigation: 3331 analysis of production records, 4111 communication/interviews, 4114 device not returned investigation findings: 3221 no findings available investigation conclusions: 4315 cause not established.B4: date of this report g6: follow up #1 h2: if follow-up, what type? h3: device evaluated by manufacture h6: coding changed based on the investigation result.D9.Device available for evaluation? no h4:device manufacture date.Evaluation summary: pentax medical has requested customers to return the used sterile distal end cap, but to date they have not yet been returned.Although the device was not returned, communications and interviews were conducted, as well as a review/analysis of the production records was performed.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 on 13-apr-2023 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 13-apr-2023 and actual date shipped were confirmed on 14-apr-2023.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.Manufacturer mdr 9610877-2023-00272, dec distal cap model oe-a63 lot number 021122 manufacturer mdr 9610877-2023-00273, duodenoscope model ed34-i10t2 serial number (b)(4).

• 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: 18243751
• MDR Text Key: 329432094
• Report Number: 9610877-2023-00272
• 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: 01/24/2024

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: OE-A63
• Device Lot Number: 0021122
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other