MAUDE Adverse Event Report: RICHARD WOLF GMBH COBRA; FIBER-URETERORENOSCOPE

Model Number	7326076
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report with additional information and investigation of this complaint.
Event or Problem Description
On september 28th , 2020, the user facility reported the following to richard wolf medical instruments corporation (rwmic): per the customer, the scope would not deflect once it was up in the kidney.Will the device be returned? yes was the device being used during a procedure when the issue occurred? yes was there any injury or illness to the patient due to the reported issue? no was there any injury or illness to any other personnel due to the reported issue? no did the issue cause a delay in the procedure being performed? no did the delay put the patient at risk? (only applicable if there was a report of delay) n/a was there a similar back-up device available for use?yes was the scheduled procedure completed? yes.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic reached out to the initial reporter to request additional information.On november 13th, 2020 the initial reporter provided new information.At this time, rwmic considers this mdr/complaint closed.However, in the event that additional information become available a follow up report will be submitted.
Event or Problem Description
Rwmic reached out to the initial reporter to request additional information.On (b)(6) 2020 the initial reporter provided new information.This follow up report is initiated to record the additional information received from the user facility.
Event or Problem Description
User facility returned the device to rwmic on october 14, 2020, and the evaluation was completed on october 22, 2020.Based on the visual and functional testing, the reported condition were confirmed.The device appeared to be damaged by laser, hard deflection.The probable root cause was determined to be user error.The device does not meet the specifications,, therefore product disposition was determined to be a routine repair.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Labeling review (ga-d347): caution! the products have only limited strength! excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.Warning! danger of injury if the auxiliary instrument is not visible through the scope! inadvertent tissue damage as well as damage to the distal end of the fiberscope and to instrument parts are possible.Insert auxiliary instruments only under visual control.Carry out manipulations only if the auxiliary instruments are fully visible through the fiberscope.Caution! to avoid damage to the laser fiber channel (18), 'do not use force to insert or withdraw the laser fiber (x) into/from the laser fiber channel (18).'insert and withdraw the laser fiber (x) through the laser fiber channel only if the instrument sheath (5) is straight and the instrument tip (4) is straight (18).Deflect the fiberscope only after the laser fiber (x) has been positioned correctly.Rwmic considers this mdr/complaint open.Rwmic will contact the user facility for missing patient information.

• Brand Name: COBRA
• Common Device Name: FIBER-URETERORENOSCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10693001
• Report Number: 1418479-2020-00032
• Device Sequence Number: 11689691
• Product Code: FGB
• UDI-Device Identifier: 04055207013755
• UDI-Public: 04055207013755
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K980401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7326076
• Device Catalogue Number: 7326076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 10/22/2020; 11/13/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 11/10/2020; 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1