MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG CYSTO SHEATH

Model Number 27026DA

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

Allegedly, during a cystoscopy procedure, the end of the instrument came off into patient.The doctor immediately retrieved and went on to complete procedure.There was no injury caused to the patient, and patient condition post-op was fine.

Manufacturer Narrative

The instrument was in use for 10 years; we think damage due to wear of use.

• Brand Name: CYSTO SHEATH
• Type of Device: SHEATH
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen 7850 3; GM 78503
• Manufacturer Contact: susie chen, complaint unit ; 2151 e. grand ave.; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4048023
• MDR Text Key: 4908786
• Report Number: 9610617-2014-00040
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2014

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: 27026DA
• Device Catalogue Number: 27026DA
• Device Lot Number: EF
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2004
• 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 Age: 94 YR