MAUDE Adverse Event Report: RICHARD WOLF GMBH SHEATH, RESECTOSCOPE, PROFILE

Model Number 8655.384

Device Problem Material Fragmentation (1261)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

Facility reported to (b)(4) that during a procedure, the ceramic tip shattered inside of patient.Doctor was able to retrieve all pieces, however, this caused a delay in that may have placed patient at risk.No injury to patient or staff reported.

Manufacturer Narrative

A thorough investigation was not completed as the actual device was not returned to the manufacturing facility as (b)(4) 2014.Photo of damaged tip was submitted.Damage occurred during use, appears due to handling.If tip were to be hit with laser, it would shatter into pieces.If tip were hit against something hard/solid, it would break into fewer but large pieces.Labeling was reviewed and found to be adequate, i.E.Intended use, indications and field of use, preparation and cautions.(b)(4) considers this matter closed.However, in the event we receive additional information, we will provide fda with follow-up information.

• Brand Name: SHEATH, RESECTOSCOPE, PROFILE
• Type of Device: SHEATH
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strabe 32; GM
• MDR Report Key: 3892015
• MDR Text Key: 4674000
• Report Number: 1418479-2014-00031
• 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: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2014,05/22/2014

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
• Device Model Number: 8655.384
• Device Catalogue Number: 8655.384
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2014
• Distributor Facility Aware Date: 05/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1