MAUDE Adverse Event Report: RICHARD WOLF GMBH FLEXIBLE FIBER-URETHRO-CYSTOSCOPE; FLEXIBLE CYSTOSCOPE

Model Number 7305.006

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/20/2016

Event Type  Injury  

Manufacturer Narrative

Actual device was not returned to richard wolf (b)(4) for evaluation as of 03/25/2016.No similar complaints on this specific product or any similar products have been reported in the last five years.Labeling was reviewed and found to be adequate.Facility has acknowledged a major change in staffing, which has resulted in failure to follow facilities reprocessing instructions as well as manufacturers ifu.Facility has taken steps in order to greatly reduce likelihood of similar events from occurring in the future.Facility has been contacted in order to gather additional information needed for this report no response as of 03/25/2016.This incident does not represent a reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public's health.Rw(b)(4) considers this matter closed.However, in the event additional information is received, rw(b)(4) will provide fda with follow-up information.(b)(4).

Event Description

Facility reported to richard wolf instruments corporation (rwmic) that a patient #1 developed an infection.Facility also reported they suspect the source of infection to be originating from failure to follow their own facilities instructions as well as failure to follow ifu instruction supplied by manufacturer.

Manufacturer Narrative

Additional patient information received on 04/19/2016.(b)(4).

• Brand Name: FLEXIBLE FIBER-URETHRO-CYSTOSCOPE
• Type of Device: FLEXIBLE CYSTOSCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corportate woods parkway; registration #1418479; vernon hills IL 60061 3110
• Manufacturer Contact: oliver ehrlich ; 32 pforzheimer street; knittlingen, 75438 ; GM 75438 ; 043351013
• MDR Report Key: 5525949
• MDR Text Key: 41152377
• Report Number: 9611102-2016-00010
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 7305.006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 104