MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KARL STORZ; OPTICAL FORCEPS

Model Number 10350H

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/06/2014

Event Type  malfunction  

Event Description

The date and information contained herein is being submitted to the fda to comply with the regulations (21 cfr part 803) pertaining to medical device reporting.This mdr is based on preliminary information received by karl storz, who has not conclusively determined the cause of the adverse event.This mdr is therefore, not intended to and shall not constitute an admission that a reportable event occurred or that any karl storz products were causally related to the incident.Allegedly, during a foreign object removal procedure, the jaw of the optical forceps broke off into the patient's lung.The doctor was able to retrieve the foreign object but not the jaw of the forceps due to its location.The doctor induced coughing to change position of the jaw within patient, but this was unsuccessful and caused patient stress due to asthmatic condition.The doctor felt it was riskier to attempt removal than leave it in at this time.Patient was release and had a follow up visit scheduled.

Manufacturer Narrative

Risk management is not releasing instrument.

• Brand Name: KARL STORZ
• Type of Device: OPTICAL FORCEPS
• Manufacturer (Section D): KARL STORZ GMBH & CO.; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; 78503 tuttlingen de; tuttlingen de ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242198201
• MDR Report Key: 3786369
• MDR Text Key: 18928682
• Report Number: 9610617-2014-00010
• Device Sequence Number: 1
• Product Code: BWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10350H
• Device Catalogue Number: 10350H
• Device Lot Number: LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/1991
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR