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

Model Number	TJF-Q190V
Medical Device Problem Codes	Use of Device Problem (1670); Dent in Material (2526)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report has been evaluated by olympus.Preliminary findings are reported.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.The forceps lever was rough-required replacement of the wire holder and o-ring.There is a dent/chip in the plastic of the cover.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported during an endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope, the patient sustained a non-specified esophageal tissue trauma.No medical or surgical intervention was required as a result of this occurrence.The patient was discharged home post-procedure as planned.
Additional Manufacturer Narrative
This report is being updated to provide investigation results.The date aware for the initial mdr is corrected to 01dec2020.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.Reproduction of the reported event by olympus: the test scope was inserted into an animal tissue simulating the body cavity.As a result, olympus confirmed the distal tip scraping the body cavity in certain test conditions.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: 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-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.
Additional Manufacturer Narrative
This report is being updated to report new and corrected data.Corrected data: physical evaluation of tjf-q190v, sn (b)(6), the scope used in this patient procedure: the tjf-q190v video scope, serial number (b)(6)was forwarded to mq for evaluation due to "large mucosal laceration on withdrawal of the scope/mucosotomy to level of the muscularis".Olympus performed a visual inspection on the received condition and was unable to replicate any issues with the video scope; including, deformations or sharp areas.No sharp edges felt on the insertion tube, or bending section-tested by running a hand along the outer portion of the described areas.The bending section cover glue is intact, and has no abnormalities.Olympus also attached a single use distal cover to the distal end.A distal cover ((b)(6)) distal cover from olympus stock was placed on the distal tip, by applying moderate pressure, while pressing down on the center section, and not at an angle.The single use distal cover securely attached to the distal tip, and did not crack at the seam.Again, the distal tip was checked for sharp areas after attaching the cover, but none were noted.After verifying that there were no issues with the single use distal covers, olympus removed the cover, without any difficulties.The video scope passed the cosmo leak test (+.0).For further testing, olympus checked the forceps elevator while in the down position.The video scope was placed into the form jig, and angulated both up and down five times in order to verify the forceps elevator position.The forceps elevator was slightly raised, but not beyond the c-body.The angles (up/down) were continuously manipulated after verification of the initial testing, and again, there was no change in the position of the forceps elevator.The video scope was purchased on october 8th, 2020 and has accumulated 12 uses since.
Event or Problem Description
Correction: the customer reports during an endoscopic retrograde cholangiopancreatography (ercp) with an evis exera iii duodenovideoscope with a single use distal cover, the patient sustained a mucosotomy to level of the muscularis.No treatment was required as a result of this injury.The patient has inpatient at the time and remained in the icu due to her gib.She was later discharged after her blood counts and vital signs returned to normal.No additional consequences to the patient were reported.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.

• 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: 11496864
• Report Number: 8010047-2021-03794
• Device Sequence Number: 3174809
• 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: K193182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• 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: 02/18/2021
• Supplement Date Received by Manufacturer: 04/27/2021; 02/10/2022
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/21/2021; 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2020
• 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: Reuse
• 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
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 52 KG