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U.S. Department of Health and Human Services

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

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX SINGLE USE DISTAL END CAP WITH ELEVATOR Back to Search Results
Model Number OE-A63
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Laceration(s) of Esophagus (2398); Blood Loss (2597)
Event Date 07/20/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event 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.
 
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Brand NamePENTAX
Type of DeviceSINGLE 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 Key10439592
MDR Text Key211010119
Report Number9610877-2020-00149
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K192245
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOE-A63
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/21/2020 Patient Sequence Number: 1
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