MAUDE Adverse Event Report: KARL STORZ ENDOVISION CMOS VIDEO CHOLEDOCHOSCOPE 8.5 FR X 50CM

Model Number 11292VS

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation is pending return of the device.

Event Description

As per report received by the factory in (b)(6) from the nhs greater glasgow and clyde in the (b)(6): when using the scope, blue material come out of the distal tip into patient; it's a blue like fiber.

Manufacturer Narrative

Section h6 was updated with additional information.

Manufacturer Narrative

Data in section h6 have been corrected to match the evaluation findings.

• Brand Name: CMOS VIDEO CHOLEDOCHOSCOPE 8.5 FR X 50CM
• Type of Device: VIDEO CHOLEDOCHOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton, ma
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton, ma
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 10094199
• MDR Text Key: 198757672
• Report Number: 1221826-2020-00061
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11292VS
• Device Catalogue Number: 11292VS
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other