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

Model Number 33300

Device Problems Bent (1059); Material Separation (1562); Cut In Material (2454); Material Distortion (2977)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Our evaluation findings for the returned 33300 outer tube: the shaft is bent, the insulation is cut and instrument failed high pot test, the distal tip is bent out of round, the locking channels in the distal tip that lock in the insert are broken off and were not returned.Because the customer said that one of the locking pieces fell into the patient and was removed, and the other one was not found to be in the patient, we suspect that it was most likely already missing before the outer tube was used in this procedure.The outer tube was manufactured in september 2007, so it is approximately 10 years old.Damages due to handling / wear and tear.

Event Description

Allegedly, during a laparoscopic myomectomy procedure, the instrument outer tube broke inside the patient.Per the customer, "the clip was noted to be in the abdomen; the piece was retrieved, but second clip was not found.X-ray was done at the end of the case, which did not show retained item." hospital reports there was no negative patient impact.

• 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: 7208030
• MDR Text Key: 98191956
• Report Number: 9610617-2018-00007
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• 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
• Device Lot Number: IC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2007
• 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: 31 YR
• Patient Weight: 60