MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. FLEX-X² FLEXIBLE URETEROSCOPE, 7.5FR

Model Number R11278AUK1

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problems Perforation (2001); Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

The customer has not responded to our attempts to gather further information, and per our understanding, they will not be returning product r11278auk1.

Event Description

Per medwatch report, ## (b)(4), received on 11/25/19, it was reported the patient was undergoing a cystoscopy, right retrograde pyelogram, and ureteroscopy with laser lithotripsy.Per the operative report, a complication was encountered when the ureteroscope became stuck in the mid ureter upon withdrawal.The provider had difficulty withdrawing or advancing.The scope was successfully withdrawn after very gentle rotation of the scope and sheath.The ureter suffered a perforation.The md noted "it appeared that the sheathing came off the ureteroscope causing the perforation." a stent was placed to treat the perforation and the patient was admitted for observation.

• Brand Name: FLEX-X² FLEXIBLE URETEROSCOPE, 7.5FR
• Type of Device: FLEX-X²
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION, INC.; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: susie chen ; 2151 east grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 9438256
• MDR Text Key: 169880144
• Report Number: 1221826-2019-00115
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K925128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial
• Report Date: 11/15/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: R11278AUK1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• 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): Hospitalization
• Patient Age: 57 YR
• Patient Weight: 98