1923569-2018-00016
Report
- Report Number
- 1923569-2018-00016
- Event Type
- Malfunction
- Date Received
- July 26, 2018
- Date of Event
- July 1, 2018
- Report Date
- August 29, 2018
- PMA / PMN Number
- K930666
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
473327: THE COMPLAINT SAMPLE WAS NOT RETURNED. ONLY A SINGLE PHOTOGRAPH WAS AVAILABLE FOR EVALUATION. THE PHOTOGRAPH DOES NOT HAVE ANY PART NUMBERS OR DATE CODE, OR OTHER ANY OTHER MARKINGS. NO EVIDENCE FOR OR AGAINST AUTHENTICITY CAN BE IDENTIFIED. THE COMPLAINT FAILURE MODE CANNOT BE VERIFIED. THE PHOTOGRAPH DOES HAVE THE APPEARANCE OF THE LUER PLUG MELTING, BUT WITHOUT A PHYSICAL SAMPLE TO INSPECT, OTHER POSSIBILITIES CANNOT BE ELIMINATED. THE MOST LIKELY EXPLANATION IS THAT THE LUER PLUG MELTED BECAUSE IT WAS EXPOSED TO A HIGH ENOUGH TEMPERATURE TO MELT A LINE THROUGH THE PLUG. THE MELTING POINT FOR THIS MATERIAL IS 143°C TO 216°C. THE SOURCE OF THE HEAT COULD HAVE BEEN ANOTHER DEVICE, OR THE CORD THAT CONNECTED TO THE BOVIE POST ON THE DEVICE PICTURED. THERE ARE NO BREAKS IN THE INSULATION ON THE DEVICE PICTURED THAT INDICATE THE DEVICE PICTURED WAS THE DEVICE THAT MIGHT HAVE CREATED A STATE LIKE A SHORT THAT COULD POTENTIALLY MELT THE PLUG. THE ROOT CAUSE OF THE COMPLAINT FAILURE MODE CANNOT BE DETERMINED. THERE IS NO VISUAL EVIDENCE IN THE PHOTOGRAPH THAT THERE IS A DEFECT IN THE INSULATION THAT COULD HAVE CAUSED A SHORT AND MELTING THE LUER PLUG. WITHOUT THE DEVICE ITSELF AND ANY DEVICE THAT COULD HAVE MELTED THE LUER PLUG AVAILABLE FOR INSPECTION, THE ROOT CAUSE CANNOT BE DETERMINED.
IT APPEARS LIKE ONE OF THE RUBBER CUPS MELTED. THE OR STAFF SAW THIS AT THE END OF THE CASE SO IT WAS USED LIKE THAT ON THE PATIENT, WHICH MAKES IT A CRITICAL ISSUE. DATE OF THE EVENT WAS (B)(6) 2018, THE PATIENT'S OUTCOME IS UNABLE TO FULLY ASSESS, IMMEDIATE OUTCOME VS LONG TERM OUTCOME, THE PATIENT WAS A 28 YEAR OLD, FEMALE, 122.24 LBS, THE PROBLEM WAS IDENTIFIED AFTER THE PROCEDURE, UNABLE TO INTERVENE, THE PROCEDURE WAS A LAPAROSCOPIC CHOLECYSTECTOMY. ALTHOUGH ASKED, NO FURTHER QUESTIONS WERE ANSWERED. THE INSTRUMENT WAS NOT TAGGED FROM THE OPERATING ROOM AND SINCE THE BLACK COLORED COVERING WAS ALL OVER DIFFERENT INSTRUMENTS IT WAS NEARLY IMPOSSIBLE TO DETERMINE WHAT INSTRUMENT IT CAME FROM SPECIFICALLY. SHE DID REQUEST MORE INFORMATION FROM THE OR BUT NEVER RECEIVED IT. THE INSTRUMENTS WERE ALL CLEANED AND PUT BACK IN TO USE. I HAVE NOT HEARD OF ANY ISSUES SINCE THAT THERE HAS BEEN ANY MELTING. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN THE DEVICE PRODUCT NUMBER AND REQUEST THE SAMPLE RETURN WITHOUT SUCCESS.
(B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.
IT APPEARS LIKE ONE OF THE RUBBER CUPS MELTED. THE OR STAFF SAW THIS AT THE END OF THE CASE SO IT WAS USED LIKE THAT ON THE PATIENT, WHICH MAKES IT A CRITICAL ISSUE. DATE OF THE EVENT WAS (B)(6) 2018, THE PATIENT'S OUTCOME IS UNABLE TO FULLY ASSESS, IMMEDIATE OUTCOME VS LONG TERM OUTCOME, THE PATIENT WAS A (B)(6), FEMALE, (B)(6), THE PROBLEM WAS IDENTIFIED AFTER THE PROCEDURE, UNABLE TO INTERVENE, THE PROCEDURE WAS A LAPAROSCOPIC CHOLECYSTECTOMY. ALTHOUGH ASKED, NO FURTHER QUESTIONS WERE ANSWERED. THE INSTRUMENT WAS NOT TAGGED FROM THE OPERATING ROOM AND SINCE THE BLACK COLORED COVERING WAS ALL OVER DIFFERENT INSTRUMENTS IT WAS NEARLY IMPOSSIBLE TO DETERMINE WHAT INSTRUMENT IT CAME FROM SPECIFICALLY. SHE DID REQUEST MORE INFORMATION FROM THE OR BUT NEVER RECEIVED IT. THE INSTRUMENTS WERE ALL CLEANED AND PUT BACK IN TO USE. I HAVE NOT HEARD OF ANY ISSUES SINCE THAT THERE HAS BEEN ANY MELTING. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN THE DEVICE PRODUCT NUMBER AND REQUEST THE SAMPLE RETURN WITHOUT SUCCESS.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 0 | 28 YR | Other |