MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PEDI WORKING ELEMENT

Model Number 27033E

Device Problems Reflux within Device (1522); Insufficient Flow or Under Infusion (2182)

Patient Problem Tissue Damage (2104)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

The karl storz instrumentation being used for the procedure was from a rental set.Our sales representative was present during the procedure, and he noted the resectoscope working element was leaking badly.He discovered the washer (part # 9466590) for use with the working element was still in the rental set case and was most likely not on the working element.A missing washer would have caused the working element to leak.

Event Description

Allegedly, during an incision of urethra valve procedure, saline was leaking from the resectoscope due to a washer that was missing; the surgeon was unable to maintain distension and removed and reinserted the scope several times to troubleshoot the problem, which resulted in a urethral tear.

• Brand Name: PEDI WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• 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: 8759084
• MDR Text Key: 149978746
• Report Number: 9610617-2019-00057
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551074893
• UDI-Public: 4048551074893
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• 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: 06/12/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 27033E
• Device Catalogue Number: 27033E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 8 DA