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

Model Number 26050XA

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/05/2013

Event Type  malfunction  

Event Description

Allegedly, during a hysteroscopy the whole ceramic beak came off the device into the patient.The doctor tried a number of times to retrieve and remove, but was unsuccessful.He replaced the damaged instrument and completed the procedure.The patient was on a 3 procedure plan, and the doctor intended to remove the piece during a hysterectomy but due to patient condition, the doctor decided not conduct the hysterectomy procedure at this time.When he does, he will remove piece.

Manufacturer Narrative

We have learned that the hospital uses 3rd party repair for this device, so it is possible the device was not repaired per original specifications.The product has not been returned.

• Brand Name: KARL STORZ
• Type of Device: RESECTOSCOPE SHEATH
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand ave; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 3640031
• MDR Text Key: 4208239
• Report Number: 9610617-2014-00001
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26050XA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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