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

Model Number TJF-Q190V

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

The eam had spoken with olympus technical support via the phone and requested instruction from olympus on what to do with both items.The single-use distal cover was returned to an olympus service center for evaluation and the reported issue was confirmed.There was a large split down the center of the cover, at the seam.The cover could not be tested with the videoscope, due to the condition, which likely occurred from removal of the accessory.Two (2) new single-use distal covers were opened and tested with the videoscope.It was noted while attempting to attach the two (2) test single-use distal covers to the distal end of the videoscope, the covers became damaged.The single-use distal cover was placed on the distal tip of the videoscope using moderate pressure, while at the same time pressing down on the center section and not at an angle.The single-use distal cover securely attached to the distal end, which was further confirmed by the positioning of the hook on the distal ring that became completely visible within the opening of the distal cover as stated in the quick reference guide.The hook had light scratches, but no significant abnormalities.The distal cover was gently pulled and twisted without slipping or coming off the distal end.The test single-use distal cover was inspected under the microscope after placement onto the videoscope.There was a hairline crack forming on the underside of the cover, on the channel side.The first test cover was removed, and another distal cover was placed onto the distal end with the same outcome.The location of the hairline crack was the same for both test distal covers.The scope was also returned to an olympus service center and is currently in the evaluation process.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus endoscopy account manager (eam) reported that during a therapeutic procedure with an evis exera iii duodenovideoscope, the single-use distal cover developed a crack and fell off into the patient.The cover was retrieved with no reported patient injury.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the user facility.

Event Description

Additional information was received from the user facility.The cap fell into the esophagus of the patient at the end of an endoscopic retrograde cholangiopancreatography (ercp) procedure.No other devices were involved in the event.The intended procedure was completed with the same device and no delay.The device was inspected prior to use and there was no crack in the tip before the start of procedure.It was confirmed that the scope tip was on correctly.The device had never been serviced by a third-party, as it was new.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer¿s investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified.It was likely the issue occurred due to the following reasons.The user's tip cover mounting method deviated from the instruction for use (ifu), so the tip cover was damaged when mounted on the device.The event occurred when the tip cover was used in a case with the damaged state.The instruction for use (ifu) states the following guidelines: 3.4 inspection of accessories: should any irregularity be observed when inspecting the single use distal cover, do not use it.A single use distal cover with irregularity could not serve the endoscope properly and/or could fall off during the examination.Using the endoscope without the single use distal cover could cause patient injury and this could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.In addition, if the single use distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed.3.5 attaching accessories to the endoscope: attaching the single use distal cover: never use the endoscope unless the single use distal cover is properly attached to the distal end.If the single use distal cover is not attached properly, it may slip off or fall off the distal end during the examination.This could result in thermal injury when the endoscope is used with high-frequency endotherapy accessories.Also, continuing the examination with the single use distal cover off may cause patient injury by the uncovered distal end of the endoscope.In addition, if the single use distal cover falls off in the oral cavity, it may cause aspiration or respiratory distress if not promptly identified and removed.

• 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: 11703655
• MDR Text Key: 268931909
• Report Number: 8010047-2021-05208
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• 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: 04/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1