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 Codes	Laceration(s) of Esophagus (2398); Blood Loss (2597)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Pentax medical became aware of a report on (b)(6) 2020 stating that the pentax medical single use disposable distal end cap with elevator (dec), model oe-a63, unknown serial number, fell off during an endoscopic retrograde cholangiopancreatography(ercp) in the middle of the patient's esophagus.The physician could see that there was no cap on the pentax medical video duodenoscope, model ed34-i10t2, unknown serial number.The procedure required medical intervention to remove the dislodged distal end cap (dec) from the patient and was saved.Also a portion of the distal end cap (dec), the deflector level "plastic cap sled", remained attached to the distal end of the duodenoscope.There was reportedly quite a lot of damage to the esophagus of the patient caused by the distal end cap (dec).The injury was found by the physician in the ventricle as he switched to a gastroscope due to abundant bleeding.The doctor found normal ratio in the esophagus down to 22 cm, but with mucosa defect to 32 cm and large defect at 39 cm.The patient was subsequently hospitalized for two days and then discharged.
Additional Manufacturer Narrative
Correction information b4: date of this report b5.Refer to h10 g6: follow up #01 h6 continued: international medical device regulators forum (imdrf) adverse event reporting health effect impact code: 2199 no health consequences or impact component code: 424 cap type of investigation: 4114 device not returned, 4111 communications/interviews investigation findings: 4248 usage problem identified investigation conclusions: 19 cause traced to user _________________ summary: pentax medical received (preliminary) feedback that they see this is a "mild" patient incident due to wrong handling, same as the first assumption which was "incorrect handling in connection with mounting the distal cap on to the duodenoscope, hence user error.The patient is well and still home and the subsequent ct scanning was ia (ok / normal).Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.
Event or Problem Description
Refer to h10.

• 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: 10439592
• Report Number: 9610877-2020-00149
• Device Sequence Number: 2578974
• Product Code: FDT
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• 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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• 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: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown