MAUDE Adverse Event Report: "WOPPLER" GRASPER; FORCEPS, GENERAL & PLASTIC SURGERY

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 02/05/2015

Event Type  malfunction  

Event Description

During the operative procedure, the "woppler" grasper broke while attempting to break bladder stone.Doctor states that instrument broke outside of the patient.Broken piece recovered in urocatch bag.Internal exam of bladder by doctor shows no evidence of retained instrument seen.X-ray taken, radiologist confirms no foreign body seen.Doctor aware.

• Brand Name: "WOPPLER" GRASPER
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• MDR Report Key: 4738346
• MDR Text Key: 5706349
• Report Number: 4738346
• Device Sequence Number: 1
• Product Code: GEN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/19/2015

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: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 119