MAUDE Adverse Event Report: KARL STORZ SE & CO. KG URETHROTOME SHEATH; URETHROTOME SHEATH, 8 FR

Model Number 27033U

Device Problem Infusion or Flow Problem (2964)

Patient Problem Urethral Stenosis/Stricture (4501)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

The images of the returned instruments showed a complete break of the sheath from the proximal end of the instrument due to possible torquing during procedure.The sheath has a date code of (b)(6) 2018.

Event Description

During a transurethral resection of posterior urethral valves procedure, the doctor claimed unable to visualize valves.Replaced the instruments with resectoscope and complained not enough flow, used a cold knife try to resect valves but it did not work.Instruments were removed and re-inserted and during manipulation the sheath broke at the junction where it connects to telescope/irrigating port part of the sheath and the scope was bent while inside the patient's urethra.The doctor switched out the set and completed the procedure with a different set of instrument and a 0.025 glide wire to enter urethra and resect valves with hook electrode.Patient's penis/urethra were edematous and bleeding noted.Doctor left a 5fr.Tube in urethra.

• Brand Name: URETHROTOME SHEATH
• Type of Device: URETHROTOME SHEATH, 8 FR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188201
• MDR Report Key: 10970435
• MDR Text Key: 229809336
• Report Number: 9610617-2020-00139
• Device Sequence Number: 1
• Product Code: ODB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2020

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: 27033U
• Device Catalogue Number: 27033U
• Device Lot Number: YR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention