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 Problems Laceration(s) (1946); Device Embedded In Tissue or Plaque (3165)

Event Date 03/15/2023

Event Type  Injury  

Manufacturer Narrative

Based on good faith effort responses via phone and email on 23-mar-2023, it was documented that the procedure involved pentax medical sterile distal end cap(dec) accessory, model oe-a63, lot number 0021082 used with pentax medical video duodenoscope model ed34-i10t2, serial number (b)(4).Also the second distal end cap used was from a different unknown lot number, and was discarded after the procedure.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of a adverse event on (b)(6) 2023 that occurred in the operating room during use in the united states.The initial complaint report was that during an ercp(endoscopic retrograde cholangiopancreatography) procedure, the physician passed the dec/ed34-i10t2 duodenoscope thru the stomach, thru the pylorus and into the duodenum.The rn in the room, said that the physician mentioned the stomach anatomy was tortuous, and he had to maneuver and torque the duodenoscope a bit to pass thru the pylorus.Upon positioning the duodenoscope near the papilla, the physician noticed the disposable end cap (model oe-a63) had fallen off.When the physician withdrew the duodenoscope to search for the dec, they could not find the dec.The physician noticed a small laceration.The physician removed the duodenoscope from the body.Then placed another disposable end cap on the same duodenoscope and ensured it was snuggly attached to the distal end of the duodenoscope and then completed the ercp procedure with no problems.The lot number of the second dec is unknown.The case was completed and went well according to the rn.Rn said the patient is fine and they do not think they even intervened on the bleed site.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 g6: follow up #1.We received the additional information: duodenoscope information: no particular abnormalities.The facility's duodenoscope handling is being carried out very carefully.Date of purchase: april 2022.Black carbon outer diameter measurement result: dia 12.4mm (same in both directions) which is within the criteria.Appearance: no lens cracks, black carbon very clean (looks like new) it's confirmed that the site fully understood the instructions for use(ifu)-based connection.They usually attach oe-a63 to the distal part of the duodenoscope without problems.The shape of the patient's stomach was longer than usual and curved in a j shape.Therefore, insertion into the duodenal bulb took time, and the doctor had to reinsert it twice.Forced pressure at this time might be the cause of small bleeding.It has been confirmed that the patient has not suffered any health damage since then.He does not think any special action is necessary.The patient anatomical factor could cause the burden to the distal part of the endoscope.In addition, the attachment of oe-a63 dec might be incomplete.Investigation is in-process.

Manufacturer Narrative

Correction information: g6: follow up #2.H3:device evaluated by manufacture.H6: coding changed based on the investigation result.Evaluation summary: the dec that fell inside the body has not been found.It is potentially cased by the user was not properly attaching the dec based on investigation , but the cause of the detachment was unknown.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured yoshikawa kasei on 01-aug-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 17-aug-2022 and actual date shipped were confirmed on 19-aug-2022.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• 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 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 16608596
• MDR Text Key: 311917609
• Report Number: 9610877-2023-00096
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: OE-A63
• Device Lot Number: 0021082
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 03/15/2023; 03/15/2023
• Supplement Dates FDA Received: 04/23/2023; 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other