MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CYSTOSCOPE-URETHROSCOPE SHEATH; CYSTOSCOPY SHEATH 19 FR

Model Number 27026DA

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

The distal tip is broken off and corrosion was found at the break and inside the stopcock.The corrosion was also seen in the customer provided image.The age of the instrument is 6 years and could be related to stress and fatigue of use.

Event Description

Allegedly, during a cystopanendoscopy, at the end of the procedure the distal tip of the sheath came off into the patient's bladder.The piece was retrieved with a grasper.There was no harm to patient.

• Brand Name: CYSTOSCOPE-URETHROSCOPE SHEATH
• Type of Device: CYSTOSCOPY SHEATH 19 FR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca 90245-5017 ; 4242188201
• MDR Report Key: 10740682
• MDR Text Key: 214753993
• Report Number: 9610617-2020-00112
• Device Sequence Number: 1
• Product Code: ODB
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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: TV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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: 75 YR