3004135191-2017-00010
Report
- Report Number
- 3004135191-2017-00010
- Event Type
- Injury
- Date Received
- January 26, 2017
- Date of Event
- October 17, 2016
- Report Date
- March 8, 2017
- PMA / PMN Number
- K133727
- Removal / Correction Number
- Z-2770-2015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
UPON RECEIPT OF THE REPORT FROM THE PATIENT, LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITIES' PHYSICIAN DIRECTLY, TO REQUEST PATIENT INFORMATION AND CLINICAL NOTES OF THE PROCEDURE. NO INFORMATION HAS BEEN PROVIDED BY THE TREATING PHYSICIAN AFTER FOUR REQUESTS. LUMENIS CONTINUES TO SEEK ADDITIONAL INFORMATION FROM THE PHYSICIAN. AN EXAMINATION OF THE VERSACUT+ TISSUE MORCELLATOR CONTROLLER BY A LUMENIS TECHNICAL EXPERT CONCLUDED THAT THE CONTROL UNIT OPERATED TO MANUFACTURER SPECIFICATIONS. THE HANDPIECE WAS RETURNED TO THE LOCAL LUMENIS OFFICE, WHICH HAS, SUBSEQUENTLY, BEEN SENT TO THE MANUFACTURING SITE IN (B)(4) FOR TESTING OF INTERNAL SPECIFICATIONS AND ANALYSIS. THE DEVICE IS CURRENTLY IN TRANSIT AND WILL BE EVALUATED UPON RECEIPT. LUMENIS INITIATED A RECALL FOR THE VERSACUT+ TISSUE MORCELLATOR HANDPIECES ON JULY 30, 2015. (REF# 3004135191-07/30/15-003-R). A REVIEW OF THE ORIGINAL CONSIGNEE LIST NOTED THAT THE USER FACILITY WAS INCLUDED ON THE CONSIGNEE LIST AND RECEIVED THE NOTIFICATION. THE CUSTOMER RETURNED TWO HANDPIECES FOLLOWING RECEIPT OF THE RECALL NOTIFICATION. THIS EVENT INVOLVED A HANDPIECE THAT WAS SUBJECT TO THE RECALL, BUT WAS NOT RETURNED BY THE CUSTOMER WHEN ITS OTHER TWO HANDPIECES WERE RETURNED TO LUMENIS. AS NOTED ABOVE, THE THIRD HANDPIECE THAT WAS INVOLVED IN THIS EVENT IS IN ROUTE TO LUMENIS, LTD. IN ISRAEL FOR RETURNED PRODUCT ANALYSIS (RPA). OUR RECORDS INDICATE THAT THE USER FACILITY HAS CONFIRMED THAT NO ADDITIONAL HANDPIECES ARE IN THEIR POSSESSION. ADDITIONAL INFORMATION: THE SUBJECT DEVICE HAND PIECE WAS RETURNED TO THE MANUFACTURING SITE FOR TESTING OF INTERNAL SPECIFICATIONS. LUMENIS TECHNICAL DESIGN AND QUALITY ENGINEERS EXAMINED THE SUBJECT DEVICE HANDPIECE. THE HANDPIECE WAS DISASSEMBLED, AND CORROSION WAS FOUND IN THE MOTOR AND PISTON SUBASSEMBLY. ROOT CAUSE FOR CORROSION IN PISTON ASSEMBLY IS NOT CLEAR. SUSPECTED ROOT CAUSE IS AGGRESSIVE DISINFECTION PROCESS / CLEANING AGENTS USED IN REPROCESSING OF THE HANDPIECE. THE CORRODED PISTON SUBASSEMBLY RESULTED IN FUNCTIONAL INCONSISTENCIES OF THE MOTOR WHICH WERE SIMILAR TO THE MALFUNCTION WHICH LED TO THE RECALL MENTIONED ABOVE.
UPON RECEIPT OF THE REPORT FROM THE PATIENT, LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITIES' PHYSICIAN DIRECTLY, TO REQUEST PATIENT INFORMATION AND CLINICAL NOTES OF THE PROCEDURE. NO INFORMATION HAS BEEN PROVIDED BY THE TREATING PHYSICIAN AFTER FOUR REQUESTS. LUMENIS CONTINUES TO SEEK ADDITIONAL INFORMATION FROM THE PHYSICIAN. AN EXAMINATION OF THE VERSACUT+ TISSUE MORCELLATOR CONTROLLER BY A LUMENIS TECHNICAL EXPERT CONCLUDED THAT THE CONTROL UNIT OPERATED TO MANUFACTURER SPECIFICATIONS. THE HANDPIECE WAS RETURNED TO THE LOCAL LUMENIS OFFICE, WHICH HAS, SUBSEQUENTLY, BEEN SENT TO THE MANUFACTURING SITE IN ISRAEL FOR TESTING OF INTERNAL SPECIFICATIONS AND ANALYSIS. THE DEVICE IS CURRENTLY IN TRANSIT AND WILL BE EVALUATED UPON RECEIPT. LUMENIS INITIATED A RECALL FOR THE VERSACUT+ TISSUE MORCELLATOR HANDPIECES ON JULY 30, 2015. (REF# 3004135191-07/30/15-003-R). A REVIEW OF THE ORIGINAL CONSIGNEE LIST NOTED THAT THE USER FACILITY WAS INCLUDED ON THE CONSIGNEE LIST AND RECEIVED THE NOTIFICATION. THE CUSTOMER RETURNED TWO HANDPIECES FOLLOWING RECEIPT OF THE RECALL NOTIFICATION. THIS EVENT INVOLVED A HANDPIECE THAT WAS SUBJECT TO THE RECALL, BUT WAS NOT RETURNED BY THE CUSTOMER WHEN ITS OTHER TWO HANDPIECES WERE RETURNED TO LUMENIS. AS NOTED ABOVE, THE THIRD HANDPIECE THAT WAS INVOLVED IN THIS EVENT IS IN ROUTE TO LUMENIS, LTD. IN ISRAEL FOR RETURNED PRODUCT ANALYSIS (RPA). OUR RECORDS INDICATE THAT THE USER FACILITY HAS CONFIRMED THAT NO ADDITIONAL HANDPIECES ARE IN THEIR PROCESSION. THE HANDPIECE IS IN TRANSIT TO FOR RPA.
A PATIENT CONTACTED LUMENIS DIRECTLY TO REPORT THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, THE PHYSICIAN EXPERIENCED A FUNCTIONAL ISSUE WITH THE OPERATIONAL PERFORMANCE OF THE HANDPIECE. AS A RESULT, THE SURGEON HAD TO STOP THE PROCEDURE AFTER 2+ HOURS AND CONVERT THE PROCEDURE TO OPEN SURGERY. THE PATIENT STATED THE PROCEDURE TOOK OVER 4+ HOURS TO COMPLETE, HE REMAINED IN HOSPITAL AN ADDITIONAL NIGHT, HE HAD TO HAVE A CATHETER FOR THREE (3) EXTRA DAYS, AND HAD AN INCISION AND STITCHES THAT WERE REPORTED TO BE PAINFUL. THE PATIENT WAS UNABLE TO PROVIDE CONFIRMATION THAT THE DEVICE USED DURING HIS PROCEDURE WAS THE LUMENIS VERSACUT+ TISSUE MORCELLATOR HANDPIECE. THUS, LUMENIS COULD NOT VERIFY THAT THE EVENT WAS ASSOCIATED WITH A DEVICE IT MANUFACTURERS. ON DECEMBER 15, 2016, LUMENIS RECEIVED INFORMATION VIA SERVICE REGARDING A SERVICE REQUEST FOR A VERSACUT+ TISSUE MORCELLATOR UNIT. FOLLOW-UP WITH THE CUSTOMER PROVIDED ADDITIONAL INFORMATION THAT APPEARED TO BE RELATED TO THE ABOVE EVENT REPORTED BY THE PATIENT. THE CUSTOMER WAS ABLE TO CONFIRM THAT THE VERSACUT+ TISSUE MORCELLATOR WAS USED IN THIS PATIENT'S PROCEDURE. UPON CONFIRMATION THAT THE EVENT INVOLVED THE LUMENIS VERSACUT+ TISSUE MORCELLATOR HANDPIECE, THE COMPANY WAS ABLE TO CONCLUDE THAT THE EVENT WAS RELATED TO A PRODUCT IT MARKETS AND REFERRED THE EVENT FOR MDR EVALUATION.
A PATIENT CONTACTED LUMENIS DIRECTLY TO REPORT THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, THE PHYSICIAN EXPERIENCED A FUNCTIONAL ISSUE WITH THE OPERATIONAL PERFORMANCE OF THE HANDPIECE. AS A RESULT, THE SURGEON HAD TO STOP THE PROCEDURE AFTER 2+ HOURS AND CONVERT THE PROCEDURE TO OPEN SURGERY. THE PATIENT STATED THE PROCEDURE TOOK OVER 4+ HOURS TO COMPLETE, HE REMAINED IN HOSPITAL AN ADDITIONAL NIGHT, HE HAD TO HAVE A CATHETER FOR THREE (3) EXTRA DAYS, AND HAD AN INCISION AND STITCHES THAT WERE REPORTED TO BE PAINFUL. THE PATIENT WAS UNABLE TO PROVIDE CONFIRMATION THAT THE DEVICE USED DURING HIS PROCEDURE WAS THE LUMENIS VERSACUT+ TISSUE MORCELLATOR HANDPIECE. THUS, LUMENIS COULD NOT VERIFY THAT THE EVENT WAS ASSOCIATED WITH A DEVICE IT MANUFACTURERS. ON DECEMBER 15, 2016, LUMENIS RECEIVED INFORMATION VIA SERVICE REGARDING A SERVICE REQUEST FOR A VERSACUT+ TISSUE MORCELLATOR UNIT. FOLLOW-UP WITH THE CUSTOMER PROVIDED ADDITIONAL INFORMATION THAT APPEARED TO BE RELATED TO THE ABOVE EVENT REPORTED BY THE PATIENT. THE CUSTOMER WAS ABLE TO CONFIRM THAT THE VERSACUT+ TISSUE MORCELLATOR WAS USED IN THIS PATIENT'S PROCEDURE. UPON CONFIRMATION THAT THE EVENT INVOLVED THE LUMENIS VERSACUT+ TISSUE MORCELLATOR HANDPIECE, THE COMPANY WAS ABLE TO CONCLUDE THAT THE EVENT WAS RELATED TO A PRODUCT IT MARKETS AND REFERRED THE EVENT FOR MDR EVALUATION.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| O| R |