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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of a complaint on 29-oct-2020 that occurred in the operating room during use in the united states.The reported complaint that the distal cap came off in the patient's mouth at the beginning of the procedure, ", involving a pentax medical accessory model oe-a63, lot #0011040, used with a pentax medical video duodenoscope, model ed34-i10t2, unknown serial number.The endoscopist inserted the endoscope in the patient's mouth but pulled it out to get a better angle for insertion and noticed the distal cap was no longer on.After several attempts to locate the distal end cap(dec) before proceeding with the procedure, it wasn't found and another distal cap was placed.When the patient was extubated the patient coughed out the distal cap.Although the distal end cap fell into the patient, there was no reported serious injury.The endoscope serial number was requested.The complaint is currently under investigation.

Manufacturer Narrative

H6 continued: international medical device regulators forum (imdrf) adverse event reporting.Type of investigation: 4114 device not returned.Investigation findings: 4248 usage problem identified.Investigation conclusions: 61 unintended use error caused or contributed to event.On 02-dec-2020, a device history record(dhr) review for pentax medical accessory model oe-a63, lot #0011040 was performed under (b)(4), the dhr review confirmed the endoscope was manufactured on 15-apr-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 for 24-apr-2020.As a result of the internal investigation performed by the manufacturer under capa number capa-pai-21-030117, it was determined the distal end cap(dec) being dislodged was not related to design or manufacturing.It was determined that improved training and clarification of labeling (ifus) would be helpful in ensuring proper attachment and continued safe use of the device.Refer to resolution section for additional details.As a result of the dec investigation and associated capa, pentax has updated the labeling (both the distal end cap ifu and the duodenoscope ifu) for ed34-i10t2.The instructions were updated to include additional wording and illustrations to help ensure a more secure attachment of the distal end cap.In addition, the warning section of the ifus have been updated to notify users of the associated risks with the distal end cap (oea63) unexpectedly becoming detached during a procedure.The update also notifies users of what immediate actions should be taken in case the event occurs.These changes were cleared in 510(k) k210710 and distributed to the installed base via a 21 cfr806.10 field corrective action (2021-004-c).In addition, a quick reference guide utilizing existing labeling was created, laminated and attached to video processor carts at all us customers of the ed34-i10t2.Training to the quick reference guide was completed at all sites, and an instructional video was produced and has been distributed to all sites.The in-service video provides instructions on proper attachment of the disposable end cap to ed34-i10t2 was created and distributed via showpad and pentax youtube.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

Event Description

Refer to h10.

• 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, 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• Manufacturer Contact: william (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 10916036
• MDR Text Key: 220248948
• Report Number: 9610877-2020-00245
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

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: 0011040
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/28/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 04/20/2023
• Date Device Manufactured: 04/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other