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

Model Number	ED34-I10T2-US
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Insufficient Information (4580)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hospital initially believed that the sharp object sticking out of the pentax medical video duodenoscope biopsy port originated from the sphincterotome, and after further review, they feel stronger that the sharp object is in fact from the sphincterotome as communicated to our pentax medical regional sales representative.This sharp portion of the sphincterotome is what the user pricked her finger on and the sharp object is not being returned to pentax medical for evaluation.(b)(4).
Event or Problem Description
Pentax medical was made aware of a complaint that occurred in the operating room after the completion of a procedure in the united states.The reported complaint was that after the successful completion of an ercp(endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2021, a nurse pricked her finger on a sharp object sticking out of the pentax medical video duodenoscope, model ed34-i10t2, serial number (b)(4).Based on additional details provided by the pentax sales rep via phone on 26-jan-2021, although no blood was noted, the nurse did go to the emergency room for evaluation after being pricked by the sharp object.During the ercp procedure a dilation balloon catheter and sphincterotome were used for a sphincterotomy, both unknown make, model, and lot numbers.The hospital initially believed that the sharp object sticking out of the pentax medical video duodenoscope biopsy port originated from the sphincterotome, and after further review, they feel stronger that the sharp object is in fact from the sphincterotome as communicated to our pentax medical regional sales representative.This sharp portion of the sphincterotome is what the user pricked her finger on.The sharp portion of the sphincterotome is not being returned to pentax medical for evaluation.The pentax medical video duodenoscope demo unit, model ed34-i10t2, serial number (b)(4) was returned on 19-jan-2021 and evaluated on 22-jan-2021, and the unit passed all function testing.On 29-jan-2021, a device history record(dhr) review for model ed34-i10t2, serial number (b)(4) was performed under ivai-21-010072, the dhr review confirmed the endoscope was manufactured on 10-jan-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 10-jan-2020.Pentax medical video duodenoscope, model ed34-i10t2, serial number (b)(4), has been routinely serviced at a pentax facility since the device was put into service on 28-aug-2020 as a demo device.
Additional Manufacturer Narrative
Evaluation summary: the complaint is not caused by a failure of the pentax equipment, but by the devices used in combination.Additional information h6: coding changed based on the investigation result.

• 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: 11325545
• Report Number: 9610877-2021-00035
• Device Sequence Number: 19693791
• Product Code: FDT
• UDI-Device Identifier: 04961333240135
• UDI-Public: 04961333240135
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Other
• 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-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2020
• 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: Female