MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE INSULATED OUTER TUBE

Model Number 33300

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2017

Event Type  malfunction  

Manufacturer Narrative

This facility experienced the same issue with two different 33300 outer tubes in two separate procedures, but only returned one of the outer tubes for evaluation (ref.Mdr 9610617-2018-02 for evaluation).Our sales representative, however, was shown both of the subject outer tubes and reports that both had a section of insulation scraped off in the same area of the shaft; this type of damage is mostly likely due to improper use/excessive torque against the trocar cannula.

Event Description

Allegedly, during a laparoscopic hysterectomy procedure, the insulation of the clickline instrument outer tube was scraped off, and pieces fell off inside paitient.The pieces were retrieved and procedure was completed with no impact on patient.

• Brand Name: CLICKLINE INSULATED OUTER TUBE
• Type of Device: INSULATED OUTER TUBE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 7177276
• MDR Text Key: 96945175
• Report Number: 9610617-2018-00003
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 4048551002308
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/17/2017

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: Physician
• Device Model Number: 33300
• Device Catalogue Number: 33300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 84