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 Device Embedded In Tissue or Plaque (3165)

Event Date 03/03/2023

Event Type  Injury  

Event Description

Pentax medical was made aware of a complaint on 10-mar-2023 that occurred in the operating room during use in the united states involving pentax medical sterile distal end cap accessory, model oe-a63, lot number 0021072 was used with pentax medical video duodenoscope model ed34-i10t2, serial number (b)(4).The complaint was initially reported that one of the caps[sterile distal end caps] malfunctioned during a procedure, and there is concern that the other caps might also be faulty.Once the caps are returned to pentax, they will be given to technology department for inspection.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: 3165.Health effect impact code: 2199 no health consequences or impact.Medical device problem code: 2907 detachment of device or device component.Component code: 424 cap.The replacement caps will be shipped to (b)(6) to (b)(6) attention for delivery on monday.Additional information received on 16-mar-2023.At the conclusion of an ercp(endoscopic retrograde cholangiopancreatography) procedure, as the physician was withdrawing the duodenoscope out of the patient the sterile single use distal end cap(dec) detached and fell off the distal end of the duodenoscope while in the patient.The physician reached in and retrieved the dislodged cap with no reported harm to the patient.An additional response was provided to an aks inquiry via email on 17-mar-2023 the md easily retrieved the fallen cap.(md stands for medical doctor).The md was surprised and not sure why it[dec] dislodged.No mention of tortuous anatomy or stress on the end of the scope.The users indicated they thought that they had done the proper technique and "heard the click".Hearing the cap "click" onto the distal end of the scope is the in service technique our representatives teach the procedure staffs.The sales rep responded that we was "not sure why they think that" when asked if "there is concern that the other caps might also be faulty".Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information b4: date of this report b5.Pentax medical video duodenoscope model ed34-i10t2, serial number (b)(6).Corrected: pentax medical video duodenoscope model ed34-i10t2, serial number (b)(6).

Event Description

Refer to h10.

Event Description

Refer to h10.

Manufacturer Narrative

Correction information: evaluation summary: we inspected the oe-a63 (9 unopened sterilized packs) and found no anomalies.However, oe-a63 that fell into the patient's body was not returned.We also ensured that the facility was trained in the proper technique of installing and removing the oe-a63.The recovered oe-a63 had no abnormalities, so the cause was unknown.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured yoshikawa kasei on 11-jul-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 and actual date shipped were confirmed on 12-jul-2022.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

Manufacturer Narrative

Correction information: f7: follow up #03.F11: updated dates.F13: updated dates.H10: correct the date of device manufacture date.Evaluation summary: a device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured yoshikawa kasei on 12-jul-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 and actual date shipped were confirmed on 02-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, 196-0 012; JA 196-0012
• MDR Report Key: 16601561
• MDR Text Key: 311925926
• Report Number: 2518897-2023-00007
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• 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: 0021072
• 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: 06/13/2023
• Distributor Facility Aware Date: 03/10/2023
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other