MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES URETERO-RENO FIBERSCOPE

Model Number URF-P5

Device Problem Difficult to Advance (2920)

Patient Problem Injury (2348)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

The urf-p5 device has not been returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.To mitigate against patient injury during use, the device instruction manual contains several warning statements regarding device operation: ¿never perform angulation control forcibly or abruptly.¿ ¿never perform angulation control or insertion/withdrawal of the endoscope¿s insertion tube without viewing the endoscopic image.¿ ¿never insert or withdraw the insertion tube abruptly or with excessive force.¿ and ¿never insert or withdraw the endoscope while the endo-therapy accessory extends from the distal end of the endoscope.¿ the instruction manual also has directions for pre-procedure inspection and operational verification of the movement of the scope device.As a preventive measure in the event of device malfunction, the instruction manual also recommends ¿be sure to prepare another endoscope to avoid that the examination will be interrupted due to equipment failure or malfunction.¿.

Event Description

One of 2.Olympus was informed that during a diagnostic ureteroscopy, the surgeon was having trouble accessing the left distal ureter using the urf-p5 device.The device was removed from the patient and a separate long rigid ureteroscope was substituted.While using the replacement ureteroscope, the surgeon noticed that the ureter had detached from the kidney.Afterwards the patient was informed that a separate laparoscopic intervention is indicated to repair the avulsed ureter.

Manufacturer Narrative

This supplemental report is being submitted to provide the physical evaluation results.A visual inspection on the received condition of the scope found multiple buckles and dents on the insertion tube, which likely caused the downward angulations on the scope to be slightly above the standard.The upward angulations were found to be within the standard.In addition, the device failed the leak test due to missing bending section cover glue at the distal end.Additionally, the bending section cover glue on the insertion tube side was cracked and lifted.Based on the evaluation results, the scope damages are indicative of improper scope handling.A review of the instrument history showed, the scope was purchased on march 26, 2018 and was last repaired on may 7, 2018.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from fbn to fgb.

Manufacturer Narrative

The oem performed further investigation based on the reported information.A dhr review was conducted for the subject scope and found no anomalies during the manufacturing process.Based on olympus¿s investigation, the exact cause of the reported event cannot be confirmed, however, the investigation concludes that the subject scope causing or contributing to the reported event is determined to be remote as the subject scope was reportedly removed from the patient without any reported problems.To mitigate the risk of patient safety, the instruction manual (chapter 3 preparation and inspection) provides warning which states, ¿before each case, prepare and inspect this instrument as instructed below.Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals.If any irregularities are suspected after inspection, follow the instructions given in chapter 10, ¿troubleshooting¿.If this instrument malfunctions, do not use it.Return it to olympus for repair as described in section 10.3.

• Brand Name: OES URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7896397
• MDR Text Key: 120964716
• Report Number: 2951238-2018-00556
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340307
• UDI-Public: 04953170340307
• Combination Product (y/n): N
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2019

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: Health Professional
• Device Model Number: URF-P5
• Device Catalogue Number: URF-P5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 09/20/2018
• Supplement Dates Manufacturer Received: 11/20/2018; 01/28/2019; 02/13/2019
• Supplement Dates FDA Received: 11/29/2018; 02/19/2019; 03/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS MR-6LA SCOPE
• Patient Outcome(s): Required Intervention