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

Model Number	27050D
Medical Device Problem Codes	Human-Device Interface Problem (2949); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Insufficient Information (4580)
Date of Event	02/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not yet returned for investigation; therefore, final root cause could not be identified.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): as reported in (b)(6): "bladder explosion".
Event or Problem 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.
Additional 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
• Common Device Name: WORKING ELEMENT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 11744792
• Report Number: 9610617-2021-00043
• Device Sequence Number: 4226172
• Product Code: HIH
• UDI-Device Identifier: 04048551077474
• UDI-Public: 4048551077474
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 27050D
• Device Catalogue Number: 27050D
• Device Lot Number: PW10
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention