MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE

Model Number	TJF-Q190V
Medical Device Problem Codes	Crack (1135); Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus was informed that after a therapeutic ercp procedure, customer found patient tissue on the cap when it was removed from the distal end of the scope.The intended procedure was completed with the same device.There was no delay in the procedure.There were no other devices replaced during the procedure.The patient was discharged home post-procedure as planned.The patient sustained non-specified gastrointestinal mucosal trauma but required no medical or surgical intervention as a result of this occurrence.Olympus was further informed that over a twenty-day period, the customer reported a cluster of eight similar events occurring during endoscopic retrograde cholangiopancreatography (ercp) procedures using an evis exera iii duodenovideoscope with a single use distal cover.These events involved gastrointestinal tissue trauma and/or tissue found in the distal cover following the procedure.These are events are reported in the following: event one: case with patient identifier (b)(6) reports the tjf-q190v used in the procedure.Case with patient identifier (b)(6) reports the maj-2315 used in the procedure.Event two: case with patient identifier (b)(6) reports the tjf-q190v used in the procedure.Case with patient identifier (b)(6) reports the maj-2315 used in the procedure.Event three: case with patient identifier (b)(6) reports the maj-2315 used in the procedure.Event four: case with patient identifier (b)(6) reports the tjf-q190v used in the procedure.Case with patient identifier (b)(6) reports the maj-2315 used in the procedure.Event five: case with patient identifier (b)(6) reports the tjf-q190v used in the procedure.Case with patient identifier (b)(6) reports the maj-2315 used in the procedure.Event six: case with patient identifier (b)(6) reports the tjf-q190v used in the procedure.Case with patient identifier (b)(6) reports the maj-2315 used in the procedure.Event seven: case with patient identifier (b)(6) reports the tjf-q190v used in the procedure.Case with patient identifier (b)(6) reports the maj-2315 used in the procedure.Event eight: case with patient identifier (b)(6) reports the tjf-q190v used in the procedure.Case with patient identifier (b)(6) reports the maj-2315 used in the procedure.The customer attributes these similar events to cracked caps (maj-2315).Customer reports speaking with the team, and they did report having difficulty in the beginning with cracking the caps.The caps were changed if they were found to be cracked.The customer also reported discovering a few caps were cracked when coming out of the packaging.This report is related to patient identifier number (b)(6), which was reported under mfr.Report number 8010047-2021-03921.
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.A device history review was performed and confirmed that the device meets all manufacturing specifications and final product release criteria.Replication test has been conducted using a test scope with a distal cover attached and pig organ.Removal of the test scope from the pig organ was experimented under two parameters "distal cover with/without slight crack" and "suction activated/not activated to remove the scope".The test result shows that tissue is embedded in the distal cover after the scope is removed with suction activated, which is observed regardless of "distal cover with/without slight crack".More tissue is embedded when small crack is present on the distal cover and suction is activated during removal.This could cause more severe damage to tissue.When there is no crack on the distal cover and suction is not activated, no tissue is embedded in the distal cover.In addition, we tested a new distal cover in our stock and verified that it conforms to the product specification.Therefore, it¿s unlikely that the reported issue was caused by manufacturing defect.The definitive cause of the reported events could not be established.Based on investigation findings, the following are presumed to be the likely causes: user operates suction while distal end opening space was near the surface of mucosa, which causes the mucosa sucked into distal cover.When user tried to remove scope in this situation, the mucosa is damaged by the edge of the distal cover.Distal cover cracks at tear-offline due to inappropriate attachment of distal cover to scope.When pressing distal end to surface of mucosa in this situation, the mucosa gets caught in the cracked cover and damaged, even though suction is not operated investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16251176
• Report Number: 9610595-2023-01384
• Device Sequence Number: 16668597
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K220587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/26/2023

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: TJF-Q190V
• Was Device Available for Evaluation?: No
• 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: 12/09/2020
• Initial Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1292-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MAJ-2315 WITH LOT NUMBER H0420
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 82 KG