SURGIPRO LL
Report
- Report Number
- 9612501-2024-00337
- Event Type
- Injury
- Date Received
- February 6, 2024
- Date of Event
- January 3, 2024
- Report Date
- February 16, 2024
- Manufacturer
- DAVIS & GECK CARIBE LTD
- Product Code
- GAW
- UDI-DI
- 10884521039568
- PMA / PMN Number
- K050947
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ACCORDING TO THE REPORTER, DURING THE SURGERY OF THE CHILD WITH TETHERED CORD SYNDROME, THE SURGEON NEEDED TO SUTURE THE DURA MATER OF SPINAL CORD WITH 0/8 902 SUTURES. WHEN THE SURGEON WAS SEWING THE THIRD STITCH, THE NEEDLE TIP BROKE WHILE THE SURGEON WAS SUTURING THE DURA MATER OF SPINAL CORD. THE HAND WASHING NURSE TOOK THE NEEDLE HOLDER, AND FOUND THAT THE NEEDLE TIP WAS MISSING. IMMEDIATELY REPORTED TO THE CIRCULATING NURSE AND THE SURGEON, AND THE HANDWASHING NURSE AND DOCTOR WERE LOOKING FOR THE BROKEN END ON THE OPERATING TABLE. AFTER SEARCHING UNDER THE MICROSCOPE, IT WAS FOUND THAT THE BROKEN PART WAS IN THE FAT LAYER. AFTER TAKING OUT THE BROKEN PART, IT WAS FOUND THAT IT WAS 0.1CM MISSING AFTER SPLICING. THE TISSUE WAS SEARCHED AGAIN AND FILMED WITH X-RAY. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. THE SURGERY WAS ENDED, AND IMMEDIATELY REPORTED TO THE HEAD NURSE, AND IT WAS NOT FOUND IN THE END, AND THE PATIENT WAS SENT OUT OF THE OPERATING ROOM.
ACCORDING TO THE REPORTER, DURING THE SURGERY OF THE CHILD WITH TETHERED CORD SYNDROME, THE SURGEON NEEDED TO SUTURE THE DURA MATER OF SPINAL CORD WITH 0/8 902 SUTURES. WHEN THE SURGEON WAS SEWING THE THIRD STITCH, THE NEEDLE TIP BROKE WHILE THE SURGEON WAS SUTURING THE DURA MATER OF SPINAL CORD. THE HAND WASHING NURSE TOOK THE NEEDLE HOLDER, AND FOUND THAT THE NEEDLE TIP WAS MISSING. IMMEDIATELY REPORTED TO THE CIRCULATING NURSE AND THE SURGEON, AND THE HANDWASHING NURSE AND DOCTOR WERE LOOKING FOR THE BROKEN END ON THE OPERATING TABLE. AFTER SEARCHING UNDER THE MICROSCOPE, IT WAS FOUND THAT THE BROKEN PART WAS IN THE FAT LAYER. AFTER TAKING OUT THE BROKEN PART, IT WAS FOUND THAT IT WAS 0.1CM MISSING AFTER SPLICING. THE TISSUE WAS SEARCHED AGAIN AND FILMED WITH X-RAY. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. THE SURGERY WAS ENDED, AND IMMEDIATELY REPORTED TO THE HEAD NURSE, AND IT WAS NOT FOUND IN THE END, AND THE PATIENT WAS SENT OUT OF THE OPERATING ROOM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504707 | SURGIPRO LL | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN | GAW | DAVIS & GECK CARIBE LTD | VP-902-X | D3B0039Y | 10884521039568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 MO | Male | Required Intervention| O |