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U.S. Department of Health and Human Services

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

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GYRUS ACMI, INC URETEROSCOPE, 43CM Back to Search Results
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.
 
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Brand NameURETEROSCOPE, 43CM
Type of DeviceURETEROSCOPE, 43CM
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key7896402
MDR Text Key120964552
Report Number2951238-2018-00557
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052044
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received09/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMR-6LA
Device Catalogue NumberMR-6LA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/07/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/20/2018 Patient Sequence Number: 1
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