MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH ONLY

Model Number 27050CA

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

The item is found the ceramic beak is broken off the end of the distal shaft.The shaft has a dent approximately midway and another near the distal end.The distal end of the sheath has a jagged edge where the beak had broken off.The sheath has staining on the inside and outside.The instrument has general wear and tear.This type of occurrence most likely is related to mechanical force.

Event Description

Allegedly, while performing a transurethral resection of prostate (turp), the ceramic tip broke off in patient's urethra when the resectoscope was being removed from patient.This caused trauma and bleeding to the urethra.No further information is available.

• Brand Name: INNER SHEATH ONLY
• Type of Device: INNER SHEATH
• 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: 11089238
• MDR Text Key: 229809776
• Report Number: 9610617-2020-00147
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551077412
• UDI-Public: 4048551077412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: 27050CA
• Device Lot Number: US04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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