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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH COBRA VISION SENSOR-URETERORENOSCOPE 9.9FR WL 680MM FLEXIBLE

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RICHARD WOLF GMBH COBRA VISION SENSOR-URETERORENOSCOPE 9.9FR WL 680MM FLEXIBLE Back to Search Results
Model Number 7356071
Device Problem Vibration (1674)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
This mdr is being submitted as part of a retrospective review of all 2016-2017 complaint files that rwmic is completing. Recently the complaint specialist determined a re-assessment of the mdr decision for this complaint was needed and that for this complaint, due to a delay in the procedure being performed that resulted in patient being at risk, an mdr should be filed. Previously in 2017, the complaint specialist at that time, determined an mdr was not needed due to "no injury to patient or staff. Backup device readily available for use. Minimal delay, minimal risk to patient. Procedure completed as scheduled. " facts of the case as reported to richard wolf by the user facility: "distal tip of scope highly sensitive to vibrations of the laser, event turning down the laser "wattage" the image did not improve. Additional information: will the device be returned? yes was the device being used during a procedure when the issue occurred? yes specifically, was the device being used on a patient when the issue occurred? yes was there any injury or illness to patient or other personnel due to issue? no did the issue cause a delay in the procedure being performed that put the patient at risk? yes was there a similar back-up device available for use? yes. Was the scheduled procedure completed? yes. How was the patient anesthetized? general? this malfunction was low risk to the patient; no issues reported to patient, no other cases reported with similar issue in 2017. No contact information was provided in the file for the user facility. Contact is being attempted through the sales rep. See manufacturers narrative for device investigation results.
 
Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh. Richard wolf medical instruments corporation is the importer of this device. Device investigation results: complaint condition was verified test equipment used: controller (b)(4) leak tester. Physical findings: leakage in the housing/cover. Conclusion: the adhesive bond to the housing/cover was not optimally executed. Because of that, moisture penetrated inside the instrument and has damaged the senor (bad picture). Action required: repair exchange required. To improve the adhesive bond to the housing/cover, a product change pk17-8900 has been started. Rwmic considers this mdr closed. Should rw receive new information, a follow-up report will be submitted.
 
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Brand NameCOBRA VISION
Type of DeviceSENSOR-URETERORENOSCOPE 9.9FR WL 680MM FLEXIBLE
Manufacturer (Section D)
RICHARD WOLF GMBH
pforzheimerstr. 32
knittlingen 75438
GM 75438
Manufacturer (Section G)
RICHARD WOLF GMBH
pforzheimerstr. 32
knittlingen 75438
GM 75438
Manufacturer Contact
heiko seider-biedermann
pforzheimerstr. 32
knittlingen 75438
GM   75438
MDR Report Key13232269
MDR Text Key294034264
Report Number1418479-2021-00057
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number7356071
Device Catalogue Number7356071
Device Lot Number5000328980
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2017
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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