MAUDE Adverse Event Report: RICHARD WOLF GMBH RESECTOSCOPE SHEATH

Model Number 86613741

Device Problems Break (1069); Electrical /Electronic Property Problem (1198); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2015

Event Type  malfunction  

Manufacturer Narrative

Device recently received device and investigation is currently inprocess.(b)(4) considers this report open and follow-up report to be sent at a later time.

Event Description

Facility reported that a device arched and damaged the tip of a second device being used during the procedure.The two impacted devices were swapped out to back up devices, readily available for use, and procedure was completed as scheduled.No injury to patient or staff reported.At least six devices are assembled together in order to operated.The two devices which had product problems and their associated mdr's are: sheath (8661.3741) - mdr9611102-2015-00004 (tip damaged).Electrode (8424.141) - mdr9611102-2015-00005 (device arched).

Manufacturer Narrative

Investigation has now been completed, this follow-up is notification of results.The actual device was returned to (b)(4) for investigation on (b)(4) 2015.The ceramic tip of the sheath had pieces broken off from the distal tip.The device was sent in together with the electrode that was being used during the time of the issue.Distal end of the electrode was missing approximately 15mm of insulation most likely the source of current causing damage to ceramic tip of sheath.Labeling was reviewed and found to be adequate.Ie intended use, indications and field of use, preparation and cautions regarding high temperatures and use of irrigation fluid.(b)(4) considers this matter closed.However, in the event (b)(4) receives additional information, a follow-up report will be provided to fda.

Event Description

This is a follow-up #1.

• Brand Name: RESECTOSCOPE SHEATH
• Type of Device: SHEATH
• Manufacturer (Section D): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; 32 pforzheimer street; knittlingen, 75438 ; GM 75438 ; 043351013
• MDR Report Key: 5186420
• MDR Text Key: 30273116
• Report Number: 9611102-2015-00004
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 86613741
• Device Catalogue Number: 86613741
• Device Lot Number: 1211303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2013
• 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 Age: 77 YR
• Patient Weight: 111