MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE CYSTOSCOPE, CHNL:7FR, 15FRX37CM

Model Number 11272CUK1

Device Problem No Apparent Adverse Event (3189)

Patient Problem Burn(s) (1757)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The customer confirmed that the medical associate received a minor burn on index finger while unplugging scope from the light source and that no treatment was necessary.

Event Description

Per the customer, a medical associate was slightly burned while unplugging cystoscope from light source.This occurred after a case.Employee touched distal end; it was hot and slightly burned employee.

• Brand Name: FLEXIBLE CYSTOSCOPE, CHNL:7FR, 15FRX37CM
• Type of Device: FLEXIBLE CYSTOSCOPE
• 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: 14287314
• MDR Text Key: 290767113
• Report Number: 1221826-2022-00063
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945185
• 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: 05/04/2022

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: 11272CUK1
• Device Catalogue Number: 11272CUK1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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