MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SEMI-RIGID 6º URETEROSCOPE W/STRAIGHT; SEMI-RIGID SCOPE

Model Number 27011L

Device Problem Material Frayed (1262)

Patient Problems Excessive Tear Production (2235); Patient Problem/Medical Problem (2688)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

We evaluated the subject semi-rigid ureteroscope and we found the distal end is a little rough from long uses.Scopes shaft is bent and with approximately 60% broken light fibers.The seni-rigid ureteroscope was in use for approximately 12 years, purchased (b)(6) 2007.

Event Description

Ureteroscope was placed into ureter and advanced toward the kidney.During removal, the ureter stuck to scope and was avulsed.The ureter could not be repaired and a nephrectomy was performed.

• Brand Name: SEMI-RIGID 6º URETEROSCOPE W/STRAIGHT
• Type of Device: SEMI-RIGID SCOPE
• 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
• MDR Report Key: 8379098
• MDR Text Key: 138408957
• Report Number: 9610617-2019-00021
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551231371
• UDI-Public: 4048551231371
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940464
• 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: 01/28/2019

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: 27011L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2015
• 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 Age: 62 YR
• Patient Weight: 127