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 01/01/2022

Event Type  Injury  

Manufacturer Narrative

H6 continued: international medical device regulators forum (imdrf) adverse event reporting health effect clinical code: 3165 device embedded in tissue or plaque health effect impact code: 4648 insufficient information medical device problem code: 2907 detachment of device or device component component code: 424 cap type of investigation: 4118 type of investigation not yet determined investigation findings: 3233 results pending completion of investigation investigation conclusions: 11 conclusion not yet available customer did not record any of the lot numbers in any of the patient charts when this occurred.At this time they do not have traceability on the distal caps on which lot number was used.Per the account, they only have two lot numbers of sterile distal end cap model #: oe-a63 on site.Lot #: 0011112 & 0021122.Therefore, the d4 lot number is listed as #: 0011112 and 0021122, two lot numbers.Pentax medical america performed a good faith effort to gather additional information regarding this event and provided an email, but has not received a response at this time.Investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.Manufacturer mdr 9610877-2024-00028, dec distal cap model oe-a63 lot number 0011112 or 0021122 manufacturer mdr 9610877-2024-00029, duodenoscope model ed34-i10t2 serial number unknown.

Event Description

Pentax medical was made aware of a complaint on 22-feb-2024 that occurred during treatment in the united states involving a pentax medical sterile distal end cap(dec) model oe-a63, lot number 0011112 or 0021122.The sterile single use distal cap was used with pentax medical video duodenoscope, model ed34-i10t2, unknown serial number.The customer reported that after a procedure the oe-a63 sterile distal end cap came off inside of the patient's mouth, however, they were able to retrieve the sterile distal end cap.This was not reported previously by the user facility's endoscopy technician supervisor.The exact date is unknown at this time, but customer stated it was approximately 22 months ago (april 2022).The customer also did not record any of the lot numbers in any of the patient charts when this occurred.At this time they do not have traceability on the decs lot numbers used.Per the account, they only have two lot numbers of sterile distal end cap model #: oe-a63 on site.Lot #: 0011112 & 0021122.Therefore, the d4 lot number is listed as #: 0011112 and 0021122, two lot numbers.Additionally the patient was not recalled for further screening.B3: the exact date of occurence is unknown at this time, but customer stated it was approximately 22 month ago (april 2022).Therefore, the b3 date of event was listed as 01-jan-2022.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 19600 12; JA 1960012
• Manufacturer Contact: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 18882951
• MDR Text Key: 337410141
• Report Number: 9610877-2024-00028
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OE-A63
• Device Lot Number: 0011112 OR 0021122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other