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 07/31/2023

Event Type  Injury  

Event Description

Pentax medical was made aware of a complaint on (b)(6) 2023 that occurred in the endoscopy suite during use in canada on (b)(6) 2023.The customer reported that a sterile single use distal end cap(dec), model oe-a63, lot number 0031102, came off during intubation and they switched to a gastroscope.The dec was lodged between the vocal cords.Hence, bx[biopsy] forceps and a basket were used to remove and retrieve the cap.The manufacturer and model of the forceps and basket were not provided.The sterile single use distal end cap(dec) was discarded and will not be returned for evaluation.The patient status in unknown at this point.The sterile single use distal cap was used with pentax medical video duodenoscope model ed34-i10t2, serial number (b)(6).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: 4638 endoscopic procedure, 4642 additional device required, 4604 delay to treatment/therapy.Medical device problem code: 2907 detachment of device or device component component code: 424 cap.Pentax medical pai received a good faith effort(gfe) response.Details below.Who was involved (clinician, technician, patient, other) - patient.What happened to the device (how did the device fail to meet its intended use or user expectation) - cap came off during intubation, switched to gastroscope.Lodged between vocal cords.Since the patient was not wearing an intubation tube at the time of the endoscopy, the patient was allowed to bite the mouthpiece and a normal endoscopy was performed.What happened to the patient (actual or potential clinical consequences from the event, patient outcome, current patient status), - patient status in unknown at this point.What procedure was involved - ercp procedure.What actions have been taken to correct the issue - bx forceps and a basket were used to remove the cap.When was it first observed - the first event was (b)(6) and second event is (b)(6), 2023.Where in the facility did it happen - endoscopy department.Where was it first observed - during procedure in endoscopy.How did it happen (if known) - unknown at this point.Was the procedure for treatment or diagnostic purposes.-treatment was there a delay in the procedure which would require medical intervention such as additional anesthesia or prolonged hospital stay.-yes 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.-yes on (b)(6) 2023, the duodenoscope was determined to be a pci loaner and remains in use at st.St.Catherines site.Pentax field rep confirmed that new nurses were working during this incident.The field rep has provided additional training on the proper use and pre-case check of the elevator cap(dec) to the new nurses.The field rep has confirmed the hospital staff is aware of, and the new staff have now been trained, on the 2021 fieldcorrective action(fca) which was conducted by pentax medical which included training on the correct use, and pre-case check.On (b)(6) 2023 training records from hospital have been requested by the field rep.Pentax canada inc.(pci) determined the duodenoscope does not need to be returned for evaluation.Additionally, a quick reference document is being prepared to address this issue.(currently in draft) if additional information becomes available, a supplemental report will be filed with the new information.Importer mdr 2518897-2023-00040, dec distal cap model oe-a63, lot number 0031102, (b)(6) 2023 procedure.Importer mdr 2518897-2023-00045, duodenoscope model ed34-i10t2, serial number (b)(6), (b)(6) 2023 procedure.Importer mdr 2518897-2023-00041, dec distal cap model oe-a63, lot number 0031102, (b)(6) 2023 procedure.Duodenoscope model ed34-i10t2, serial number (b)(6), (b)(6) 2023 procedure.

Event Description

Refer to h10.

Manufacturer Narrative

Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.________ evaluation summary the returned cap[dec] was inspected at pentax medical canada and was in new condition revealing that is was not attached correctly.The duodenoscope was inspected on (b)(6) 2023, and the sterile distal end cap diameter and other specifications were within the manufacturer's specifications, so we were able to test any (b)(6) and it was connecting and disconnecting fine.The duodenoscope has been returned to the user facility on (b)(6) 2023.Pentax medical canada has confirmed by email that the customer confirmed verbally that training was conducted to address the user related error.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the duodenoscope was manufactured by pentax medical miyagi on (b)(6) 2020 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 (b)(6) 2020.Patient condition status was provided on (b)(6) 2023 by pci and patient is noted as fine and no further reports or concerns were received.Importer mdr 2518897-2023-00040, dec distal cap model oe-a63 lot number 0031102, (b)(6) 2023 procedure importer mdr 2518897-2023-00045, duodenoscope model ed34-i10t2 serial number (b)(6), (b)(6)2023 procedure.Importer mdr 2518897-2023-00041, dec distal cap model oe-a63 lot number 0031102, (b)(6) 2023 procedure importer mdr 2518897-2023-00044, duodenoscope model ed34-i10t2 serial number (b)(6), (b)(6)2023 procedure.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• 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: 17666376
• MDR Text Key: 322476552
• Report Number: 2518897-2023-00044
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ED34-I10T2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2023
• Distributor Facility Aware Date: 08/18/2023
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention