MAUDE Adverse Event Report: KARL STORZ GERMANY 27 FRENCH OBTURATOR 27 FRENCH OBTURATOR RESECTOSCOPE

Model Number 27040AK

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/20/2017

Event Type  Injury  

Event Description

Ceramic obturator end broke off during procedure. The physician was unable to retrieve the remaining piece. The remnant piece was retained in the bladder. On(b)(6) 2017, the surgeon performed a second surgical procedure to retrieve the retained piece. The surgery was successful. The company is aware. Ccn, cms (b)(4).

• Brand Name: 27 FRENCH OBTURATOR
• Type of Device: 27 FRENCH OBTURATOR RESECTOSCOPE
• Manufacturer (Section D): KARL STORZ GERMANY; 14 mechanics st.; southbridge MA 01550
• MDR Report Key: 6767187
• MDR Text Key: 82022347
• Report Number: MW5071374
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (Y/N): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: RISK MANAGER
• Type of Report: Initial
• Report Date: 08/03/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/03/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 27040AK
• Device LOT Number: TX01
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Is this a Reprocessed and Reused Single-Use Device?: No

Patient TREATMENT DATA

Date Received: 08/03/2017 Patient Sequence Number: 1