MAUDE Adverse Event Report: RICHARD WOLF GERMANY (GMBH) ENDOSCOPE, URETEROSCOPE, VIPER; FLEXIBLE URETEROSCOPE

Model Number	7325.071
Medical Device Problem Codes	Material Fragmentation (1261); Device Handling Problem (3265)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Richard wolf medical instruments (rwmic) (contract manufacturer) received actual device from user facility on 04/18/2017.A visual inspection of device found insertion tube and vertebrae damaged to the point the entire shaft must be replaced.Many holes in hose and a portion of hose is missing, approximately 10 inches from tip.Device also had moisture in system due to the many cuts and/or holes.User facility contacted in an effort to gather additional/missing information.Rwmic has not been able obtain enough information to determine the extent of injury, minor vs.Life threatening injury, at this time therefore rwmic defaulted to serious injury and submitting a mdr.Any information received had been entered.Additional attempts will be performed in an effort to gather additional/missing information.Device to be sent to richard wolf (b)(4) (manufacturer) on 04/26/2017 for further evaluation.No similar events resulting in an mdr have occurred on this device in the last three years.Manufacturer date: 06/08/2016 purchase date: 01/20/2017 service dates: n/a rwmic considers this matter closed.However, in the event rwmic receives additional information, a follow-up report will be provided to fda.
Event or Problem Description
Richard wolf medical instruments corporation (rwmic) was notified by user facility that during the removal of the device in question the insertion tube fell apart and the patient was injured.
Additional Manufacturer Narrative
Richard wolf medical instruments corporation (rwmic) (contract manufacturer) received investigation results from richard wolf (b)(4) (manufacturer) on 18sep2017.Rwgmbh performed visual inspection and leak test on device.Found surface of the distal tube and shaft badly damaged due to mechanical overload/distortion.Moisture penetrated inside and damaged the deflection and optical system.Damage caused by improper and/or rough handling by the user and reprocessing staff.This type of damage is not possible under normal circumstances.Rwmic considers this matter closed.However, in the event rwmic receives additional information, a follow-up report will be provided to the fda.
Event or Problem Description
Follow up #1.Richard wolf medical instruments corporation (rwmic) (contract manufacturer) received investigation results from richard wolf (b)(4) (manufacturer) on 18sep2017.The following boxes have been updated/completed: date description of this report, all manufacturers, device manufacturer.

• Brand Name: ENDOSCOPE, URETEROSCOPE, VIPER
• Common Device Name: FLEXIBLE URETEROSCOPE
• Manufacturer (Section D): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6526186
• Report Number: 1418479-2017-00008
• Device Sequence Number: 1202073
• Product Code: FGB
• UDI-Device Identifier: 04055207013694
• UDI-Public: 04055207013694
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 7325.071
• Device Catalogue Number: 7325.071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR