MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TUBE, INNER ROTATABLE CERAMIC; UROLOGY SHEATH

Model Number 27050XB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

Customer will not return the device for evaluation.We learned from our field service that they use 3rd party repairs to support this product.

Event Description

Allegedly, during a urologic stent insertion, ceramic tip broke off in patient; the surgeon irrigated the bladder and removed a 2mm piece and suspect it is missing another small piece but did not see anything else.No harm to the patient and the procedure was completed with no further surgical intervention.

• Brand Name: TUBE, INNER ROTATABLE CERAMIC
• Type of Device: UROLOGY 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 e. grand avenue; el segundo, ca, ; 2188201
• MDR Report Key: 10040439
• MDR Text Key: 190386545
• Report Number: 9610617-2020-00063
• Device Sequence Number: 1
• Product Code: FBO
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27050XB
• Device Catalogue Number: 27050XB
• Device Lot Number: AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2009
• 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 Weight: 64