SHARK/S-LINE
Received Jul 3, 2019 · Event occurred May 14, 2019
Report 1418479-2019-00030 · MDR key 8759049
Device
Generic name
Cutting Electrode Bipo Sterile, For Single Use
Manufacturer
Richard Wolf GmbhModel number
4624.1313Catalog number
4624.1313
Lot number
4500242351
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
RWMIC HAS REQUESTED ADDITIONAL AND MISSING INFORMATION FROM USER FACILITY AND MANUFACTURER. RWMIC WILL SUBMIT A FOLLOW UP REPORT UPON RECEIPT OF ADDITIONAL INFORMATION AS APPROPRIATE. RWMIC CONSIDER THIS CASE OPEN.
Description of Event or Problem
ON JUNE 10TH, 2019, RWMIC WAS NOTIFIED THAT REPORT MW5087014 WAS SUBMITTED TO FDA FROM THE USER FACILITY. USER FACILITY REPORTED THE FOLLOWING: DURING CYSTOSCOPY, TRANSURETHRAL RESECTION OF PROSTATE WITH BIPOLAR LOOP, THE LOOP (TIP) OF THE 26FR BIPOLAR ELECTRODE BROKE OFF INSIDE THE PATIENT. SURGEON UNABLE TO VISUALIZE THE BROKEN PIECE INSIDE THE PATIENT USING THE CYSTOSCOPE. REMOVED REMAINDER OF ELECTRODE FROM STERILE FIELD, PLACED IN BIOHAZARD BAG WITH PACKAGE. X-RAY TAKEN NEGATIVE FOR FOREIGN BODY.