MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG WORKING ELEMENT

Model Number 27040EB

Device Problems Failure to Cut (2587); Mechanics Altered (2984)

Patient Problem Blood Loss (2597)

Event Date 05/27/2014

Event Type  malfunction  

Event Description

The data and information contained herein is being submitted to the fda to comply with the regulation (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 turp, the doctor stated prostate chips were not adequately sheared off when using this device leading to excessive bleeding and difficulty in controlling that bleeding.Doctor switched to monopolar instrumentation to address bleeding and complete the case.Patient was a jehovah witness and would not accept blood transfusions.Patient remained in icu for 48 hours until blood count stabilized and then another 3 days in hospital for recovery.Patient condition is good now.

Manufacturer Narrative

The devices have not been returned for evaluation yet, but will be.

• Brand Name: WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand ave; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4008428
• MDR Text Key: 20268957
• Report Number: 9610617-2014-00035
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040EB
• Device Catalogue Number: SAME
• Device Lot Number: UW
• 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: 07/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR