MAUDE Adverse Event Report: HOYA CORPORATION PENTAX PENTAX; LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C

Model Number EG-3870UTK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Date 11/09/2022

Event Type  Injury  

Event Description

Pentax medical became aware of a potential adverse event reported on (b)(6) 2022 involving pentax medical video gastroscope model eg-3870utk, serial number (b)(4).The customer reported a perforation in the right lateral duodenal wall occurred during insertion of endoscope into the duodenal bulb, followed by loop reduction (withdrawal of scope) which led to scope tip going forward through the duodenal wall.The patient was admitted and sent to surgery.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

International medical device regulators forum (imdrf) adverse event reporting health effect clinical code: (b)(4).Health effect impact code: (b)(4).Medical device problem code: (b)(4)component code: (b)(4).The investigation is inprocess.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information: f7: follow up #01.F10 coding changed based on the investigation result international medical device regulators forum (imdrf) adverse event reporting component code: 525 tube changed to 841 imager.Evaluation summary: in this case, it is speculated that there was no malfunction of the device, and that the doctor performed the endoscopy with the same intent as other models with different specifications (the subject is unknown), and unintentionally perforated the patient.It has been about 20 years since the model was released, and since no changes have been made to the bending performance specifications during that time, it is considered to be an event unique to the facility.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

Event Description

Customer reported perforation in the right lateral duodenal wall occurred during insertion of scope into the duodenal bulb, followed by loop reduction (withdrawal of scope) which led to scope tip going forward through the duodenal wall.From physician: typically, as long as tip of the cla (linear) scope is appropriately angled/deflected and pointed towards d2, the scope tip will slide into d2/d3 during this reduction maneuver, but with the angle of the duodenal apex relative to large eus probe and long bending segment/wide deflection angle of the pentax scope, my theory is that angle was too sharp for this scope to handle in this case.Description of any actions taken: patient admitted and sent to surgery.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.

Event Description

Refer to h10.

Manufacturer Narrative

Correction information: b4: date of this report, b5.Refer to h10, f7: follow up #01, f11: updated dates, f13: updated dates, f10 coding changed based on the investigation result.International medical device regulators forum (imdrf) adverse event reporting health effect impact code: 4607 hospitalization or prolonged hospitalization, 4625 additional surgery, 4614 serious injury/illness/impairment.Evaluation summary: the patient recovered uneventfully.But patient spent a week in the hospital and required open surgical laparotomy for repair.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C
• Manufacturer (Section D): HOYA CORPORATION PENTAX; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 15933277
• MDR Text Key: 304994592
• Report Number: 2518897-2022-00220
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333228409
• UDI-Public: 04961333135899
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2023,02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EG-3870UTK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2023
• Distributor Facility Aware Date: 11/24/2022
• Device Age: 43 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 04/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization