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.

• 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

• Date FDA Received: 03/24/2023
• 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
• Date Manufacturer Received: 03/15/2023
• 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