MAUDE Adverse Event Report: HOYA CORPORATION PENTAX PENTAX; VIDEO COLONOSCOPE

Model Number	EC38-I10L
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer requested a rma for no video image error message, scope not connected on a ec38-i10l- video colonoscope.The customer stated the message is check scope connection-error 5.The issue was observed in the operating room prior to use.There were no patient or user injuries, adverse events, delay or medical intervention reported.
Additional Manufacturer Narrative
The reported customer complaint of no video image error message was confirmed through evaluation of the device.Evaluation findings were listed as: image blackout, passed dry leak test, passed wet leak test, up/down angulation knob play, right/left angulation knob play.The device was refurbished, cleaned, and disinfected, angle adjustments made, and video image calibrated.Should additional information become available, a supplemental report will be filed.

• Brand Name: PENTAX
• Common Device Name: VIDEO COLONOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12827719
• Report Number: 9610877-2021-01547
• Device Sequence Number: 11868543
• Product Code: FDF
• UDI-Device Identifier: 04961333232383
• UDI-Public: 04961333232383
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EC38-I10L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2018
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown