MAUDE Adverse Event Report: KARL STORZ; BIOPSY FORCEP

Lot Number FL01

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/03/2016

Event Type  Injury  

Event Description

Pt in the operating room had a urology procedure completed.Surgeon attempted to biopsy posterior bladder wall, but biopsy forceps broke and a metal piece was seen falling to the dependent portion of bladder.Piece of metal identified in the bladder and an attempt was made to remove but could not be retracted through the scope.An alligator forcep was used to grasp piece of metal but when the alligator forcep was opened but no metal piece seen.Imaging completed showing no retained metal piece identified.Bladder was irrigated thoroughly.

• Type of Device: BIOPSY FORCEP
• Manufacturer (Section D): KARL STORZ
• MDR Report Key: 5453428
• MDR Text Key: 38812999
• Report Number: MW5060331
• Device Sequence Number: 1
• Product Code: FCL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: FL01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR