MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT WITH FINGER GRIP ACTION

Model Number 27050D

Device Problems Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Insufficient Information (4580)

Event Date 02/23/2020

Event Type  Injury  

Manufacturer Narrative

Device was not yet returned for investigation; therefore, final root cause could not be identified.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): as reported in (b)(6): "bladder explosion".

Event Description

As per a manufacturer incident final report we received from the factory in germany: the surgery was extended into a laparatomy to repair the bladder.

Manufacturer Narrative

The 27050d working element device was used with the following accessories: 27050sc / resectoscope sheath, 26 fr.270500a / inner sheath for 27050 sc.270400c / standard obturator.27050l / coagulating electrode, pointed.27050g / cutting loop, 24/26 fr.277 / unipolar high frequency cord, 300 cm.The affected part was sent for further investigation.According to the results, the failure could not be reproduced.There is no indication that the products caused the reported failure.This incident was related to patient condition and/or complication by user procedure.The most probable root cause is that major gases were generated from human tissues pyrolysis or intracellular water electrolysis because of high temperature when cutting and coagulation of tissue.There have been no similar incidents reported.

• Brand Name: WORKING ELEMENT WITH FINGER GRIP ACTION
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 11744792
• MDR Text Key: 247949773
• Report Number: 9610617-2021-00043
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551077474
• UDI-Public: 4048551077474
• Combination Product (y/n): N
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27050D
• Device Catalogue Number: 27050D
• Device Lot Number: PW10
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention