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

Model Number 33300W

Device Problems Material Fragmentation (1261); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/23/2018

Event Type  Injury  

Manufacturer Narrative

The device was evaluated by the manufacturer, karl storz in (b)(4).Per their evaluation, "the bayonett deformed and the insulation of the sheath damaged (cuts and scratches) all over the length.The deformation of the bayonett pre-damaged the bayonett wing and lead to the final break.The damages in the insulation would have been justification enough to take this part out of service long ago, as the insulation capability is corrupted and proper cleaning is not possible anymore.This is clearly given in ifu on page 1, 5 safety instructions, second warning, and page 2 seventh warning.Special this would have led to detect the damage straight after the procedure and prevented the patient from injury.The device in question has been in service for near 12 years.".

Event Description

We received a vigilance report from our manufacturer in (b)(6) which was filed with the national competent authority, (b)(6) in (b)(6).Allegedly, a female patient underwent a lap chole procedure on (b)(6) 2018.A month after the procedure, the patient complained about abdominal pain in the operated region.A subsequent ct scan showed a 4mm metal fragment situated below the umbilicus.A second procedure to remove the fragment was performed on (b)(6) 2018.

• Brand Name: CLICKLINE INSULATED OUTER TUBE
• Type of Device: 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: 8276481
• MDR Text Key: 134062678
• Report Number: 9610617-2019-00015
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551133972
• UDI-Public: 4048551133972
• Combination Product (y/n): N
• PMA/PMN Number: K935071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33300W
• Device Catalogue Number: 33300W
• Device Lot Number: CD592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2006
• 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): Required Intervention