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MAUDE Adverse Event Report: WOLF WOLF; RESECTOSCOPE
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WOLF WOLF; RESECTOSCOPE
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Device Problem
Material Twisted/Bent (2981)
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
Event Date
01/19/2023
Event Type
malfunction
Event Description
Inner and outer sheath metal of the cystoscope bent during a procedure.
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Brand Name
WOLF
Type of Device
RESECTOSCOPE
Manufacturer
(Section D)
WOLF
richard wolf medical instruments corporation
353 corporate woods parkway
vernon hills IL 60061 3110
MDR Report Key
16512151
MDR Text Key
311078806
Report Number
16512151
Device Sequence Number
1
Product Code
FJL
Combination Product (y/n)
N
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
User Facility
Reporter Occupation
Other Health Care Professional
Type of Report
Initial
Report Date
01/20/2023
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
Device Operator
Health Professional
Was Device Available for Evaluation?
Yes
Is the Reporter a Health Professional?
Yes
Was the Report Sent to FDA?
Yes
Date Report Sent to FDA
01/20/2023
Device Age
2 YR
Event Location
Hospital
Date Report to Manufacturer
03/09/2023
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
03/09/2023
Is This a Reprocessed and Reused Single-Use Device?
No
Type of Device Usage
Unknown
Patient Sequence Number
1
Patient Age
24090 DA
Patient Sex
Male
Patient Weight
105 KG
Patient Race
White
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