MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY ELECTRODE, CUTTING

Model Number 27050G

Device Problem Material Separation (1562)

Patient Problem Internal Organ Perforation (1987)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

Hospital not releasing.

Event Description

Allegedly, at the end of a turbt procedure, the doctor was using the cutting loop when she heard a "pop." she x-rayed the patient and determined that the bladder had been perforated.The patient was moved into the main or and a laparotomy was performed to repair the bladder.Patient responded well to the surgery and is in good condition after the surgery.There was no malfunction of the electrode noted during procedure, and upon examination afterwards the or personnel saw no damage to the electrode.Cause of perforation undetermined.

• Brand Name: ELECTRODE, CUTTING
• Type of Device: ELECTRODE, CUTTING
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 6661541
• MDR Text Key: 78227792
• Report Number: 9610617-2017-00046
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 27050G
• Device Catalogue Number: 27050G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2016
• Initial Date FDA Received: 06/22/2017
• 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: 68 YR
• Patient Weight: 81