MAUDE Adverse Event Report: GYRUS ACMI, INC URETEROSCOPE, 43CM

Model Number MR-6LA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

The mr-6la 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 instructions for use document contains several warning statements regarding device operation.Prior to the procedure, ¿check the outer surface of the shaft prior to each use to make certain that the instrument is free of any cuts, holes, rough surfaces, sharp edges, or protrusions.Do not use if damage is suspected or discovered.¿ during the procedure, ¿avoid using excessive torque/force on the endoscope, as patient injury and possible damage to the instrument could result.¿ ¿keep the distal tip of any electrode, probe, laser fiber or other ancillary device in the field of view at all times when active.¿ and ¿caution: undue stress on the endoscope shaft may cause bending or breaking.If the distal shaft is bent due to the rigors of a difficult procedure, do not attempt to straighten it; damage can result.¿ as a preventive measure in the event of device malfunction, the instructions for use document also recommends ¿due to the high fragility of flexible endoscopes, always have a backup scope available.¿.

Event Description

Two of 2.Olympus was informed that during a diagnostic ureteroscopy, the surgeon was having trouble accessing the left distal ureter using another ureteroscope device.The other ureteroscope was removed from the patient and the mr-6la long rigid ureteroscope was substituted.While using mr-6la 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 additional information.Based on the olympus' investigation, a search of prior complaints concludes the bent out tube is most likely attributed to user mishandling.The scope was manufactured in january 2016.A dhr review was conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that the product was processed without incident and therefore there is no internally assignable cause for the reported problem.We cannot discern a root cause for the reported failure mode.

Manufacturer Narrative

This supplemental report is being submitted to provide the physical evaluation results.A visual inspection on the received condition of the scope was performed and found the outer tube bent at the middle portion area.Additionally, there are black spots on the optical image.Scratches on the light guide post connector were noted.There was no damage noted on the eyepiece.

• Brand Name: URETEROSCOPE, 43CM
• Type of Device: URETEROSCOPE, 43CM
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 7896402
• MDR Text Key: 120964552
• Report Number: 2951238-2018-00557
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K052044
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MR-6LA
• Device Catalogue Number: MR-6LA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS URF-P5 SCOPE
• Patient Outcome(s): Required Intervention