MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE URETEROSCOPE 7.5FR X 67.5CM, CHNL:3.6FR

Model Number 11278AUK1

Device Problem No Apparent Adverse Event (3189)

Patient Problem Burn(s) (1757)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

Device was returned for evaluation.Per the evaluation summary: thermal damage at proximal section 191mm from shaft adaptor in shaft caused leak and distal lens separation.Over bend at distal end 207mm from distal tip in shaft.Pink hue in view.Deflection fails at 285° up/250° down.Shaft damage and user injury was due to misuse/handling of the laser instrument.

Event Description

Per information received by on-site endoscopic specialist on (b)(6) 2020: during a case, there is thermal damage 3-4 inches down from the handle and the laser burned the doctor; no patient impact.Further information received during our initial complaint investigation: the doctor was burned by a laser fiber that fired through the scope.The incident happened on (b)(6) 2020 during a cystoscopy with laser lithotripsy of kidney stone.Another flexible ureteroscope was opened to finish the procedure.The doctor is doing well; there was small burn through the glove.He finished the case and continued with his scheduled cases.

• Brand Name: FLEXIBLE URETEROSCOPE 7.5FR X 67.5CM, CHNL:3.6FR
• Type of Device: FLEXIBLE URETEROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14338385
• MDR Text Key: 291230135
• Report Number: 1221826-2022-00071
• Device Sequence Number: 1
• Product Code: FGB
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 11278AUK1
• Device Catalogue Number: 11278AUK1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2020
• 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): Other
• Patient Sex: Male