MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; SINGLE USE DISTAL END CAP WITH ELEVATOR

Model Number	OE-A63
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Pentax medical was made aware of an event that occurred in the operating room during an endoscopic retrograde cholangiopancreatography(ercp) for tumor jaundice in the emea region.The user reported that a distal end cap(dec) was disconnected at the beginning of the examination in the stomach of the patient and was removed traumatically involving penax medical accessory model oe-a63, lot number 0011050(from (b)(6) report), used with a pentax medical video duodenoscope, model ed34-i10t2, serial number (b)(4).The dec was withdrawn with an extraction basket with esophagus wound and the examination was stopped.The user facility reported a complaint on 20-aug-2020 in regards to pentax medical video duodenoscope, model ed34-i10t2, serial number (b)(4) for bending rubber winding on the wrong position, insertion flexible tubing(ift) worn out.Investigation in-process.
Event or Problem Description
Per an email from pentax france on (b)(6) 2020, the user facility contacted pentax on (b)(6)2020, stating that the replacement duodenoscope i10t received as a replacement is not usable due to the presence of mist on the image in regards to pentax medical video duodenoscope, model ed34-i10t2, serial number (b)(6).Investigation in-process.
Additional Manufacturer Narrative
H6 continued: international medical device regulators forum (imdrf) adverse event reporting health effect impact code: 4648 insufficient information.Component code: 424 cap.Type of investigation: 4111 communications/interviews.Investigation findings: 4248 usage problem identified.Investigation conclusions: 19 cause traced to user.Summary: based on the investigation, the concluson was user mishandling and customer retraining was required.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Common Device Name: SINGLE USE 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: 10577347
• Report Number: 9610877-2020-00159
• Device Sequence Number: 10136365
• Product Code: FDT
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: OE-A63
• Device Lot Number: 0011050
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 08/24/2020; 08/24/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 09/25/2020; 06/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown