MAUDE Adverse Event Report: RICHARD WOLF GERMANY (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 08/12/2015

Event Type  malfunction  

Event Description

Facility notified a (b)(4) sales representative that during a procedure the ceramic tip of the device broke and landed inside of patient.Doctor was able to easily retrieve foreign object and completed procedure as scheduled with readily available backup device.No injury to patient or staff reported.(b)(4).

• Brand Name: SHEATH, RESECTOSCOPE, PROFILE
• Type of Device: SHEATH
• Manufacturer (Section D): RICHARD WOLF GERMANY (GMBH); 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 5057752
• MDR Text Key: 25057743
• Report Number: 1418479-2015-00029
• 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
• Reporter Occupation: Nurse
• Report Date: 09/04/2015,08/13/2015

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: Physician
• Device Model Number: 8655.384
• Device Catalogue Number: 8655.384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2015
• Distributor Facility Aware Date: 08/13/2015
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR