MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY CYSTYO-URETHROSCOPE SHEATH; CYSTO SHEATH

Model Number 27026BA

Device Problem Material Separation (1562)

Patient Problem Abrasion (1689)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

Device not released by hospital.

Event Description

Allegedly, during a cystoscopy (left retrograde pyelogram, left ureteral stent placement) the distal end of instrument broke off into patient.The broken piece was retrieved.The patient received an abrasion to the prostatic urethra; a foley catheter was inserted.The doctor states the abrasion will heal on its own.The procedure was completed.

• Brand Name: CYSTYO-URETHROSCOPE SHEATH
• Type of Device: CYSTO SHEATH
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 5596314
• MDR Text Key: 44024297
• Report Number: 9610617-2016-00071
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/22/2016

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: Physician
• Device Model Number: 27026BA
• Device Catalogue Number: 27026BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 39 YR
• Patient Weight: 158