MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG N.A.; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 27040XA

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

Event Type  malfunction  

Event Description

During a cystourethroscopy with transurethral resection of 4 cm bladder tumor, the resectoscope tip broke apart while inside of patient / "cystoscopy, turbt" procedure.Both parts were retrieved and removed from patient without harm.No complications as a result.

• Brand Name: N.A.
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 7062821
• MDR Text Key: 93050712
• Report Number: 7062821
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: OV 05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN:CYSTOURETHROSCOPY WITH TRANSURETHRAL RESEC
• Patient Age: 88 YR
• Patient Weight: 61