MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO DUODENOSCOPE

Model Number	ED34-I10T2
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Misassembly by Users (3133)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Premarket identification: ife= import for export.(b)(4).
Event or Problem Description
Pentax medical was made aware of an event that occurred in the operating room during use in (b)(6).The reported complaint received on (b)(6) 2020 stated that the user facility used a pentax medical demo video duodenoscope, model ed34-i10t2 - serial number (b)(4), at the user facility for an emergency endoscopic retrograde cholangiopancreatography(ercp) without a pentax medical representative on site.During the ercp, the facility mistakenly used a cap intended for use with the facilities model ed34-i10t endoscope on the pentax medical video duodenoscope model ed34-i10t2 endoscope.The facility used a t scope cap, model oe-a55, instead of the disposable sterile distal end cap, model oe-a63.As a result, the oe-a55 with an unknown lot number, fell off within the patient.No retrieval was performed during the procedure.The physician made the decision to let the cap pass naturally.Once the cap passes, it will be discarded by the patient, so will be unavailable for evaluation.The facility is removing the ed34-i10t2 scope from the fleet to ensure that this does not happen again.No additional information was provided at the time of reporting.Pentax (b)(4) provided an update on 23-sep-2020 via email providing the pentax medical video duodenoscope serial number for the ed34-i10t2 and they also provided an update for the patient status stating the patient is good and is aware of the cap that was lost.The demo video duodenoscope was returned to pci on 05-oct-2020 for evaluation.Findings included a minor cover glass chip documented as wear and tear.Pentax model ed34-i10t2, serial number (b)(4), has been routinely serviced at a pentax facility as a demo device.
Additional Manufacturer Narrative
Evaluation summary: it was caused by improper mounting of oe-a63 and ed34-i10t2.Also, filed action was carried out and ifu was distributed.

• Brand Name: PENTAX
• Common Device Name: VIDEO DUODENOSCOPE
• 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: 10652906
• Report Number: 9610877-2020-00165
• Device Sequence Number: 11652227
• Product Code: FDT
• UDI-Device Identifier: 04961333240135
• UDI-Public: 04961333240135
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: ED34-I10T2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown