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

Model Number 8655.384

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2015

Event Type  malfunction  

Event Description

Facility notified a (b)(4) sales representative that during a procedure the ceramic tip of the device in question chipped and chip landed inside of patient.Doctor was able to easily retrieve chip and completed procedure as scheduled.No injury to patient or staff reported.An investigation will not be completed by (b)(4).If and when device is received by (b)(4) it will be sent to manufacturer (rw(b)(4)) for investigation.No other (b)(4) complaints on this device type in the last three years.Request for additional information, no response as of 08/10/2015.Richard wolf considers this matter closed.However, in the event we receive additional information, we will provide fda with the follow-up information.

• Brand Name: SHEATH, RESECTOSCOPE, PROFILE
• Type of Device: SHEATH
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strabe 32; GM
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy.; vernon hills IL 60061
• Manufacturer Contact: 353 corporate woods pkwy.; vernon hills, IL 60061
• MDR Report Key: 4992280
• MDR Text Key: 22947590
• Report Number: 1418479-2015-00027
• Device Sequence Number: 1
• Product Code: FDC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Report Date: 08/10/2015,07/30/2015

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: 08/10/2015
• Distributor Facility Aware Date: 07/30/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1