MAUDE Adverse Event Report: RICHARD WOLF GMBH (GERMANY) FIBER-URETERORENOSCOPE; URETEROSCOPE, PRODUCT CODE: FGB

Model Number 7325.071

Device Problems No Display/Image (1183); Material Integrity Problem (2978); Optical Problem (3001)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Investigation is currently in process.Rwmic and rw (b)(4) considers this report open for missing information and investigation report.

Event Description

Richard wolf medical instrument corporation was informed by facility that during a procedure the screen goes dark.Device complaint report answers are provided below: product 7325.071 will be returned for investigation.The device was being used on a patient when the issue occurred.There was no injury of illness to the patient when the issue occurred.The delay in the procedure put the patient at risk.A similar back-up device was not available for use.The scheduled procedure was completed.Rwmic provided complaint information to the manufacturer rw (b)(4) on (b)(6) 2018.Manufacturer's report number is included in this report.

Manufacturer Narrative

Follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: user facility was contacted 3 times in an effort to collect patient information and user information.As of 07/26/2018, rwmic has not received a response.Ifu includes a caution for limited strength."excessive force will cause damage, impair the function, and therefore endanger the patient.Immediately before and after each use, check products for damage, loose parts, and completion.Do not use the products if they are damaged or incomplete, or have loose parts".Ifu includes a warning for "danger of injury if the auxillary instrument is not visible through the scope.Inadvertent tissue damage as well as damage to the distal end of the fiberscope and to instruments parts are possible" ifu includes a caution for image quality, "increased risk potential is the image is blurred!.Danger of injuring the patient.Stop the intervention for safety reasons if the image is blurred.Check the image quality of the fiberscope before use".Ifu includes checks and functional checks.Functional checks include manual leakage test immediately after use or each time before reprocessing.Rwmic considers this complaint and mdr closed.Follow-up reports will be sent to fda as required.

Event Description

Follow-up report #1.User facility returned the device to rwmic on 04/19/2018, rwmic completed the investigation on 06/27/2018.Investigation summary is below: product appearance is used.The complaint condition was not verified.Investigator did report: the distal hose as cut.The distal hose leaks.The ocular leaks.Master bond is cracked.Hard deflection.Equipment used: camera setup and leak tester.(b)(4) was repaired, the complete shaft was replaced.

• Brand Name: FIBER-URETERORENOSCOPE
• Type of Device: URETEROSCOPE, PRODUCT CODE: FGB
• Manufacturer (Section D): RICHARD WOLF GMBH (GERMANY); registration number 9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7476544
• MDR Text Key: 107458308
• Report Number: 9611102-2018-00008
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207013694
• UDI-Public: 04055207013694
• Combination Product (y/n): N
• PMA/PMN Number: K980401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/26/2018,04/07/2018

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: 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: 04/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2018
• Distributor Facility Aware Date: 04/07/2018
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 04/19/2018
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other