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

Model Number ED34-I10T2

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/11/2023

Event Type  Injury  

Manufacturer Narrative

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: 4607 hospitalization or prolonged hospitalization, 4638 endoscopic procedure.Medical device problem code: 2907 detachment of device or device component, 1069 break component code: 424 cap, 525 tube, 772 cover.According to an email received on january 27, 2023, this circumstance led to a necessary transfer to another hospital (sanaklinikum offenbach) department of pulmonology.After several bronchoscopic interventions, it was then possible to remove the distal end cap.Patient had to be ventilated for several days.Afterwards, patient left the hospital.Post-procedurally, a colleague from bu-germany confirmed that it was impossible to attach a new sterile distal end cap (oe-a63) securely to the ed34-i10t2.We investigated the returned ed34-i10t2 and found the following errors: 1.) light guide cover glass damaged.2.) instrument channel severely kinked distally.Otherwise there are no abnormalities on the distal end body and also not on the rest of the endoscope.At 12.5mm, the distal bonding of the bending cuff is 0.2mm smaller than specified and is therefore within the tolerance range.There is a clearly audible click when putting on our test dec cap.The cap sits firmly on the end body and can only be loosened by pressing it in from the side.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.Due to this event, pentax medical filed the following mdr reports: mfr report number 2518897-2023-00001 with the fda for pentax medical video duodenoscope model ed34-i10t2, serial number a110393 mfr report number 2518897-2023-00002 with the fda for pentax medical sterile distal end cap accessory, model oe-a63, lot number 0011012.

Event Description

Pentax medical was made aware of a complaint on (b)(6) 2023 that occurred in the operating room during use in the emea region involving pentax medical video duodenoscope model ed34-i10t2, serial number a110393 that was used with pentax medical sterile distal end cap accessory, model oe-a63, lot number 0011012.The reported complaint that the sterile single use distal end cap(dec) had become detached from the distal end of the duodenoscope and remained in the lungs.This issue happened after the duodenoscope, model ed34-i10t2, was mistakenly inserted into the trachea.The patient was transferred to another hospital.In the respiratory department, several bronchoscopies were performed and the dec was removed.Although the patient required a ventilator for several days before being discharged from the hospital, there was no report of patient harm.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

Correction information: f7: follow up #01.Evaluation summary: in this case, there was no abnormality in the product (endoscope and tip cap) from the reported contents and additional investigation results.Chipping of lcb cover glass and deformation of the operation channel were found in the actual machine, however none of them were related to the fixation of dec.It was determined that the tip cap had come off due to an unintended force which applied to the tip cap by inserting it into the bronchi, which is not the application site.It is possible that the tip cap was incompletely attached, but no further information was obtained.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 24-apr-2019 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 24-apr-2019.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: 16308873
• MDR Text Key: 308913938
• Report Number: 2518897-2023-00001
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04961333233007
• UDI-Public: 04961333233007
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ED34-I10T2
• Device Lot Number: A110393
• 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: 04/26/2023
• Distributor Facility Aware Date: 01/27/2023
• Device Age: 45 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other