MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. OPTICAL GRASPING FORCEPS

Catalog Number 101350H

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/06/2014

Event Type  malfunction  

Event Description

During a procedure to remove a thumb tack from a patient's lung, the tip of a long optical grasping forcep broke off and fell into the patient's lung cavity.The thumb tack was removed.The broken tip from the grasper was not visible for removal during the procedure.X-ray shows the grasper tip in the lung post op.

• Brand Name: OPTICAL GRASPING FORCEPS
• Type of Device: FORCEPS
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245 501
• MDR Report Key: 3638689
• MDR Text Key: 15324049
• Report Number: 3638689
• Device Sequence Number: 1
• Product Code: BWH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 101350H
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2014
• Patient Sequence Number: 1
• Patient Age: 12 YR