MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. 7.5 X 675MM FLEXIBLE URETERSCOPE ASSEMBL; FLEX-X2S

Model Number R11278AUK1

Device Problems Loose or Intermittent Connection (1371); Retraction Problem (1536); Material Twisted/Bent (2981)

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

Event Date 02/01/2020

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 via us mail, the patient was undergoing bilateral ureteroscopies due to ureteral stones.Flexible ureteroscope placed into the left ureter.Laser was used to bust up the stones.As procedure continued, physician tried to pull the scope back.He met resistance and felt the scope was stuck.Retraction techniques utilized/attempted.Rigid cystoscope utilized.Upon, inspection, the outside lining of the flexible scope was very loose and was bunching.

• Brand Name: 7.5 X 675MM FLEXIBLE URETERSCOPE ASSEMBL
• Type of Device: FLEX-X2S
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.; 91 carpenter hill road; charlton, ma
• Manufacturer (Section G): KARL STORZ ENDOVISION, INC.; 91 carpenter hill road; charlton, ma
• Manufacturer Contact: susie chen ; 2151 east grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 10027040
• MDR Text Key: 189970528
• Report Number: 1221826-2020-00057
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551395875
• UDI-Public: 4048551395875
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• 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: 75 YR
• Patient Weight: 106