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

Model Number TJF-Q190V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been received by olympus for physical evaluation.The definitive cause for the customer's experience can not be determined at this time.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# 2951238-2020-00523.

Event Description

It is reported during an endoscopic retrograde cholangiopancreatography (ercp) for biliary stent removal, using an evis exera iii duodenovideoscope, the patient sustained a moderate mucosal tear the entire length of the esophagus.Cap assisted examination was performed and did not reveal deep penetrating injury.The patient was sent home with eight weeks of twice daily proton pump inhibitor (ppi) treatment.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was returned to an olympus service center for evaluation.Visual inspection and testing did not replicate the issue, but estimation was able to confirm difficulty in attaching the single use cover (maj-2315) to the scope at an angle.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The test scope was inserted into animal tissue simulating the body cavity.As a result, the legal manufacturer confirmed the distal tip scraping the body cavity in certain test conditions.A capa has been opened to continue this investigation.The probable cause is not yet available.The following is referenced in the instructions for use (ifu) regarding the single use cover: "never use a single use distal cover with cracks or pinholes.Replace it with a new one.If a single use distal cover with cracks or pinholes is used, it could fall off during the examination and/or, it may cause thermal injury due to electric current leaks from cracks or pinholes when high-frequency cauterization treatment is performed.Also, using the single use distal cover with cracks may cause patient injury due to sharp edges." "push the center on the top of the single use distal cover.Otherwise, it may cause the break of the portion on the single use distal cover such as the tear off line.".

Manufacturer Narrative

This report is being updated to report new and corrected data.New information is reported in: b1, b5, d8, d10, h7, h9, h10.Corrected data is reported in: b5.Correction and preventative action (capa) investigation has been opened to further investigate this issue.

Event Description

Corrected/new information: 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 tjf-q190v used in the procedure.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.The customer reported the scope ¿broke off¿.Upon physical inspection/evaluation of the returned device, olympus could not confirm the customer¿s report.There were no pieces of the video scope broken off.The single use distal cover (maj-2315) was not returned for evaluation.Olympus did note cracking on the insertion tube side of the bending section cover glue, which was still intact/attached to the video scope.

• Brand Name: EVIS EXERA III 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: 10945432
• MDR Text Key: 219506718
• Report Number: 8010047-2020-09812
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2022

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
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 01/20/2021; 02/10/2022
• Supplement Dates FDA Received: 02/11/2021; 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1292-2021
• Patient Sequence Number: 1
• Treatment: MAJ-2315, LOT UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 113 KG