MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG KARL STORZ; ELECTRODE

Model Number 27050G

Device Problem Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Perforation (2001)

Event Date 02/06/2014

Event Type  malfunction  

Event Description

Allegedly, during a turp procedure, the bladder was perforated.Procedure was completed.No further info available at this time.

Manufacturer Narrative

Risk management is not releasing instrument.Risk manager did not provide info on whether the impact to the pt was related to a malfunction of the device.

• Brand Name: KARL STORZ
• Type of Device: ELECTRODE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen 7850 3; GM 78503
• Manufacturer Contact: susie chen ; 2151 e. grand ave.; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 3788606
• MDR Text Key: 4442165
• Report Number: 9610617-2014-00011
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/04/2014

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: Health Professional
• Device Model Number: 27050G
• Device Catalogue Number: 27050G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR