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

Model Number TJF-Q190V

Device Problems Crack (1135); Use of Device Problem (1670); Material Twisted/Bent (2981)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has been evaluated by olympus.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.Physical evaluation of the complaint device reveals: the scope passed the leak test.All switches were ok.There are deep dents on the hold ring of the cover body.The rubber glue is cracked and requires replacement.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during an endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope, tissue was found in the distal end cap.The physician inserted the endoscope again and confirmed there was an injury, tissue damage at the esophageal/gastro (eg) junction and greater curvature of the stomach.No medical or surgical intervention was required as a result of this occurrence.The patient was discharged home post-procedure as planned.

Manufacturer Narrative

This report is being updated to provide investigation results.Corrected information is reported in g3.The date aware for the initial mdr is corrected to 14jan2021.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.3.5 attaching accessories to the endoscope: attaching the single use distal 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.Correction and preventative action (capa ) investigation has been opened to further investigate this issue.Conclusion: the definitive cause of the reported events could not be established.Based on investigation findings, the following are presumed to be the likely causes: 1) 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.2) distal cover cracks at tear-off line 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.

Event Description

Additional information: case with patient identifier (b)(6) reports the tjf-q190v used in this procedure.Case with patient identifier (b)(6) reports the maj-2315 used in the procedure.This has happened multiple times at this facility (previously reported).The customer attributes the 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.

Manufacturer Narrative

This report is being updated to report additional information.Additional information is reported in b5, and d8.

• 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: 11507346
• MDR Text Key: 241046554
• Report Number: 8010047-2021-03852
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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?: No
• 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: 02/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 04/27/2021; 02/10/2022
• Supplement Dates FDA Received: 05/21/2021; 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2020
• 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
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 115 KG