MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE CYSTOSCOPE

Model Number 11272CU1

Device Problems Material Disintegration (1177); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

Allegedly, during a urethra repair due to gun shot wound (gsw), insulation material from distal end of the scope came off inside the pt.Surgeon was able to remove some pieces by using a semi-rigid scope with another grasping forceps.Another scope was used to complete procedure.

Manufacturer Narrative

The hospital is not releasing the flexible scope.According to their laparoscopy manager, this scope was last serviced by (b)(4) a third party repair company they used for this scope and other instruments.We show no record of this hospital purchasing this flexible scope from us.

Manufacturer Narrative

The device was not returned for eval at the time the mdr was filed.Now that device has returned, an eval is available.The angle cover, thread wrap, epoxy bond on the thread wrap, monocoil, mask, and shaft of flexible cystoscope are all non karl storz materials.There is a leak in angle cover, and there are voids around the distal light guides due to the leak.The control wire is broken at the distal end causing the loss of deflection; tracking is off due to the control wire damage.There are 4 broken image fibers and white matter on the ocular mount.The damages are due to third party repairs.

• Brand Name: FLEXIBLE CYSTOSCOPE
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; charlton MA
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill rd.; charlton MA 01507 5256
• Manufacturer Contact: susie chen ; 2151 e grand avenue; unit #3010202439; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4720455
• MDR Text Key: 5747011
• Report Number: 1221826-2015-00028
• 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: User Facility,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11272CU1
• Device Catalogue Number: 11272CU1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2005
• 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): Required Intervention
• Patient Age: 32 YR