MAUDE Adverse Event Report: RICHARD WOLF GMBH RESECTOSCOPE-SHEATH

Model Number 8661.3741

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Facility reported to one of richard wolf medical instruments corporation (rwmic) customer repair specialist 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: 1) sheath (8661.3741) - mdr1418479-2015-00031 (tip damaged).2) electrode (8424.141) - mdr1418479-2015-00032 (device arched).

• Brand Name: RESECTOSCOPE-SHEATH
• Type of Device: SHEATH
• Manufacturer (Section D): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 5123846
• MDR Text Key: 27351491
• Report Number: 1418479-2015-00031
• 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
• Reporter Occupation: Other
• Report Date: 10/02/2015,09/04/2015

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: 8661.3741
• Device Catalogue Number: 8661.3741
• Device Lot Number: 1211303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2015
• Distributor Facility Aware Date: 09/04/2015
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1