MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TUBE,INNER,CERAMIC INSULATION; INNER TUBE

Model Number 27040XB

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

Medwatch #mw5089606 does not have a facility name, address or contact information provided.We searched our data base and do not see any returning orders, which fit this criteria, therefore we cannot gather further information.In addition, this model of sheath has a ceramic beak at the distal end, not "plastic" end.We do not know if the instrument has been repaired by a 3rd party and replaced the beak material.

Event Description

Per medwatch report, #mw5089606 received on (b)(6) 2019, it was reported the "plastic end piece of instrument broke during a procedure".

• Brand Name: TUBE,INNER,CERAMIC INSULATION
• Type of Device: INNER 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 east grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 9200073
• MDR Text Key: 188078436
• Report Number: 9610617-2019-00098
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551076569
• UDI-Public: 4048551076569
• Combination Product (y/n): N
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Type of Report: Initial
• Report Date: 09/23/2019

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?: Yes
• Device Operator: No Information
• Device Model Number: 27040XB
• Device Lot Number: GB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2008
• 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