MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problem Failure to Clean Adequately (4048)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

The customer initially returned the subject device for repair of the sheathing.During repair, foreign material was found in the forceps elevator.This event was reported via patient identifier (b)(6).Additional information was received from the customer.The subject device was used on multiple patients.Two patients developed cholangitis after procedures involving the subject device.The infections were discovered (b)(6) 2022.The patients were treated with antibiotics and reported as 'doing well' at this time.The facility reported no positive test results have been obtained from the subject device to date.This event involves 2 reports: (b)(6): patient 1 infection, (b)(6): patient 2 infection.This report is 2 of 2 for (b)(6): patient 2 infection.

Manufacturer Narrative

The subject device was evaluated.In addition to foreign material found in the forceps elevator, the evaluation identified the following: leak found in the channel tube, bending tube is deformed and plastic distal end cover is dented and failed insulation test, aw-cylinder has discoloration, suction cylinder has discoloration, adhesive around objective lens has discoloration, switch box has scratch, light, guide, grip , switch cover, connecting tube has scratch, and up/down/right/left knob has scratches, control unit is shaved, forceps elevator corroded, switch cover has a crack, light guide lens has crack, switch 1 has a cut, forceps elevator connector is dirty and scope connector is dent, due to damage on channel tube, water tightness is lost.Universal cord has coating peeling, due to a crack on plastic distal end cover, insulation resistance value at distal end does not meet the standard value, service repair noted that the findings found on the device are attributed likely a result of wear and tear and customer handling issue.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less over 6 years since the subject device was manufactured.Based on the results of the investigation, a root cause regarding the patient infection and the foreign material in the forceps elevator could not be identified.Since information regarding the patient infection was provided by the user after repair work on the subject device was completed, and culture testing was not performed by a third-party lab, a relationship between the reported event and the subject device could not be determined.In addition, reprocessing steps by the user was not provided and nonconformity was not confirmed on the forceps elevator of the subject device.This supplemental report includes a correction to g2.¿other¿ was corrected from ¿(b)(6)¿ to ¿(b)(6).¿ also, a correction was made to g3 of the initial medwatch.The aware date should be 02-mar-2022.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation per capa-200413.Based on the results of the investigation, although foreign material was observed at the forceps elevator, the specific material could not be identified.It could not be determined why the foreign material remained.In addition, although dirt was observed in the electrical connector, the specific material could also not be identified.No physical damage was noted where the foreign material remained.Also, the information on reprocessing steps by the user was not provided.Therefore, the root cause of these issues could not be determined.This supplemental report includes a correction to d9.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9610595.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14358061
• MDR Text Key: 291396409
• Report Number: 8010047-2022-08048
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other