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 Tissue Damage (2104)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.The user discarded the subject single use distal cover maj-2315.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the cleaning of the subject device after the procedure, there was a strip of tissue (strip of 1 cm) between the forceps elevator and the single use distal cover maj-2315.The intended procedure was the gastroscopy with the subject device for assessment of the papilla, status after cholecystectomy and seizure-like abdominal pain.The intended procedure was completed successfully.The endoscope was then reintroduced to the patient and there appeared to be bleeding and lesion of the tissue in the stomach and the lesion of the tissue could clearly be related to the found tissue underneath the single use distal cover maj-2315.The tissue had the same shape as the lesion form the stomach flap, the length was the same and the edges of the wound appeared to be scraped.The lesion was closed by 5 clips put on.After that the user completed the procedure.After the endoscopy, the patient was observed for over one hour and she was discharged without complaints.Next day the patient had no more complaints.Before and after use the single use distal cover maj-2315 and the subject device had been completely intact.The single use distal cover maj-2315 had been properly attached to the subject device.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information.Olympus medical systems corp.(omsc) and olympus europa se & co.Kg (oekg) had a web meeting with the user facility and obtained the following information from the user.The sideward movement of the scope on the surface of the stomach could be related to the ¿scrape¿.It is reasonable that the scope can scratch the cardia, when the scope goes into the esophagus.After the ercp procedure, the air inside the stomach is sucked from the patient.The distal end of tjf-q190v can be near the cardia, so the mucosa will be easily sucked into the notch area of the single use distal cover maj-2315.Furthermore the endoscopist can easily retract the endoscope from the cardia into the esophagus while sucking out the air from the stomach.Also, it is possible that during retraction from the duodenum to the duodenal bulb this could happen.Even though the suction will not be performed in the duodenal bulb, the endoscope will turn (angulation and twist) at the duodenal bulb.Theoretically, this may also make the mucosa injury.The single use distal cover causes the mucosal injury because it has a sharp edge.By sucking out the air the tissue can become trapped into the notch by moving the endoscope the tissue can be scraped off the single use distal cover was fitted correctly on the endoscope, there were no abnormalities visually and tactilely both before and after the procedure.The suction valve which is defendo brand is used.However, it is unknown that whether the suction valve which is the reusable olympus or the disposable defendo was used, because there was a delivery problem at that time.It is considered that performing suction near the cardia will cause the mucosa laceration.To avoid it, it is recommended to perform suction when the endoscope distal end has enough distance from the lower esophageal sphincter and is moving freely in the stomach so the endoscope is far away from any stomach mucosa.The physicians don¿t need to change the way of suction when using lateral-view or direct-view endoscopes.Because, it would not be difficult for physician to recognize if the lateral-view endoscope has enough distance from the stomach wall or not.In addition, the endoscopist has to suck out the air and only then remove the endoscope (after stopping sucking out the air).Furthermore, oekg obtained the information from the user facility by the e-mail that the maximum suction is 36 kpa that is commonly used with most of all the endoscopy procedures.The service department of oekg checked the subject device and found that there were no malfunctions on the distal end and the forceps elevator of the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide the subject device evaluation result.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation but was returned to olympus europa se & co.Kg (oekg).Oegk checked the subject device and found the following.- the forceps elevator was not moved without manipulation of forceps elevator lever on the control section.- the movement of the forceps elevator was smooth.- there was no sharp edge, while attaching single use distal cover.- there was no significant gap between single use distal cover and the distal body while attaching single use distal cover.Also oekg obtained following additional information from the user facility.- the lot number of the single use distal cover was h9124.- there was no damage on the single use distal cover and the subject device, both before and after the procedure.- the single use distal cover was attached correctly.(the user always conducts extra checks whether the distal cover is loosened or not.) - the user did not use lens cleaner.- the doctor was an expert.- in the user facility, similar event did not occur in the past except the suggested event.- single use distal covers were stored in the original box properly - the doctor thought that ¿the strip of tissue was caught between slit of the single use distal cover when air in stomach was sucked.When the scope was moved in that state, the tissue might be scraped off.¿ - the suction function was on and was used to deflate the patient¿s stomach.However, it was unknown whether it was used when the device was removed.- it is assumed that the detected strip of tissue came from gastric fold near the cardia (the scar was confirmed on gastric fold near the cardia).- the size of the strip of tissue was 1cm.Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from oekg, there was the possibility that this phenomenon was attributed to the following mechanism.- the user operated the suction while the distal end opening space was near the surface of mucosa, which caused the mucosa sucked into single use distal cover.When user tried to remove the subject device in this situation, the mucosa was damaged by the edge of the single use distal cover.- the single use single use distal cover cracked at tear-off line by inappropriate attaching of the single use distal cover to the subject device.When pressing the distal end of the subject device to the surface of the mucosa in this situation, the mucosa got caught in the cracked single use distal cover and damaged, even though suction was not operated.Olympus stated the appropriate handling of tjf-q190v and the counter measures against abnormalities in the instruction manual of tjf-q190v.

• 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
• MDR Report Key: 11086010
• MDR Text Key: 227353185
• Report Number: 8010047-2020-11067
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: K193182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2021

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?: No
• Device Operator: No Information
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/14/2021; 04/22/2021
• Supplement Dates FDA Received: 02/09/2021; 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other