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

Model Number	TJF-Q190V
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports during an endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope with a single use distal cover, the patient experienced a tear of the gastric cardia/ge junction, largest component 2cm.This caused a 2 unit gastrointestinal bleed requiring transfusion as well as urgent repeat endoscopy with hemostatic clip placement.The patient was already inpatient.During the ercp, a partially migrated 10fr x 10cm plastic pigtail stent was removed with a rat toothed forceps (boston scientific m00538350) and this was removed with the scope in its entirety.Indwelling 10fr plastic straight stent was removed with a snare through the elevator channel.Cannulation was with visiglide wire and olympus long-wire extraction balloon.Dilation was performed with a cook 5-7-10fr push dilator.Ultimately 7fr x 10cm plastic double pigtail stent and 10fr x 10cm plastic biliary stents were replaced.The distal cover lot number cannot be provided, or sent for evaluation as it was discarded.There was no abnormality in the appearance of the scope or distal cover before or after the procedure.There were no significant anatomical challenges that caused or contributed to the reported event, however, procedurally, the removal of the migrated biliary stent with a rat toothed forceps with the elevator design potentially could have been the point of injury to the gastric cardia.The patient's current condition is stable, discharged outpatient and considering transition to hospice for advanced cancer diagnosis.
Additional Manufacturer Narrative
Concomitant devices: maj-2315, bs rat tooth forceps, snare, visiglide, long-wire, cook push dilator, double pigtail biliary stents the device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00437.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.The suspect device was returned to olympus for annual inspection may 11, 2022.During that inspection, the following device issues were identified and repaired: ·insufficient angulation.·play on angulation control knob out of standard value.·hold ring dented.·a-rubber glue cracked.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.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: important information ¿ please read before use: examples of inappropriate handling: applying suction with the distal end of the endoscope in prolonged contact with the mucosal surface, with higher suction pressure than required, or with prolonged suction time may cause bleeding and/or lesions.Conclusion: root cause of the suggested event cannot be conclusively specified.Consideration: based on investigation findings, the following are possible causes:.Since it was reported that the patient's esophagus was injured upon withdrawal of the device, we presumed that the event was likely occurred due to a).A) the event likely occurred by the mechanism i) described in investigation result 4.When user operates suction while distal end opening space was near the surface of mucosa, it causes the mucosa sucked into distal cover.In replication testing it was found out that the mucosa is maintained in a sucked state for several seconds after suction operation is stopped.Therefore, even if suction operation is not performed during withdrawal and distal cover is not cracked, the event may occur if scope is withdrawn immediately after suction operation is stopped.B) removal of the migrated biliary stent with a rat toothed forceps potentially could have been the point of the suggested event.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Common Device Name: 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: 14777046
• Report Number: 8010047-2022-10558
• Device Sequence Number: 5025302
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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: 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: 05/26/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 51 KG