MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY RESECTOSCOPE SHEATH WITH BEAK; SHEATH WITH CERAMIC BEAK

Model Number 27040BO

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2015

Event Type  malfunction  

Manufacturer Narrative

Instrument was evaluated and confirmed that the ceramic beak broke completely off the distal end of the instrument.The instrument has a date code of mg; it has been in use for approximately 12 years.It is possible that damage is due to stress overload/wear of long use.

Event Description

Allegedly, doctor was performing a direct vision iu procedure, when the beak came off the instrument.The doctor immediately retrieved piece.Procedure was completed with no injury to the patient.

• Brand Name: RESECTOSCOPE SHEATH WITH BEAK
• Type of Device: SHEATH WITH CERAMIC BEAK
• 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: 5043493
• MDR Text Key: 25348000
• Report Number: 9610617-2015-00071
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Report Date: 08/13/2015

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: Physician
• Device Model Number: 27040BO
• Device Catalogue Number: 27040BO
• Device Lot Number: MG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2003
• 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: 70 YR