TRI-STAPLE 2.0
Report
- Report Number
- 1219930-2023-00580
- Event Type
- Malfunction
- Date Received
- February 16, 2023
- Date of Event
- December 5, 2022
- Report Date
- March 16, 2023
- Manufacturer
- COVIDIEN LP LLC NORTH HAVEN
- Product Code
- GDW
- UDI-DI
- 10884521543591
- PMA / PMN Number
- K160176
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CONCOMITANT MEDICAL PRODUCT/S: EGIAUXL ENDOGIA ULTRA UNIV XL STAPLER LOT #:P2J0020. 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.
ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. NO INFORMATION RE GARDING THE SPECIFIC CUSTOMER ISSUE THAT OCCURRED WITH THE DEVICE WAS AVAILABLE. UPON EXAMINATION OF THE SAMPLE, IT WAS FOUND THAT THE RELOAD WAS PARTIALLY FIRED, AND THE ANVIL CLAMPING MECHANISM WAS DEFORMED. FUNCTIONAL TESTING REQUIRED THE INTERLOCK TO BE OVERRIDDEN AND THE RELOAD WAS APPLIED TO TEST MEDIA. THE RELOAD INTERLOCK WAS TESTED AND FOUND TO FUNCTION PROPERLY. DEFORMED ANVIL CLAMPING MECHANISM MAY OCCUR EITHER BY FIRING OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE OR BY FIRING WITH AN OBSTACLE INCORPORATED IN THE JAWS. IN EITHER OF THESE CIRCUMSTANCES, IT WILL BECOME INCREASINGLY DIFFICULT TO ACTUATE THE FIRING HANDLE AND THE INSTRUMENT RETURN KNOBS WILL BE DIFFICULT TO RETRACT. IN ADDITION, STAPLES MAY NOT FORM PROPERLY, AND TISSUE MAY NOT BE FULLY TRANSECTED. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: PREOPERATIVE RADIOTHERAPY MAY RESULT IN CHANGES TO TISSUE. THESE CHANGES MAY, FOR EXAMPLE, CAUSE THE TISSUE THICKNESS TO EXCEED THE INDICATED RANGE THICKNESS FOR THE STAPLE SIZE. CAREFUL CONSIDERATION SHOULD BE GIVEN TO ANY PRE-SURGICAL TREATMENT THE PATIENT MAY HAVE UNDERGONE AND IN CORRESPONDING SELECTION OF STAPLE SIZE. 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 A LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING FIRST FIRING ON THE STOMACH TISSUE, THE FIRST STAPLER WAS MAKING A LOUD CRUNCHY NOISE THAT MADE SURGEON UNCOMFORTABLE. THE SECOND STAPLER MADE THE SAME LOUD NOISE BUT THE SURGEON CONTINUED FIRING AND THE STAPLE LINE LOOKED FINE AS EXPECTED. THE SECOND STAPLER WAS USED UNTIL THE CASE WAS COMPLETED WITHOUT ANY ISSUE. THE PATIENT HAS NO INJURY AND WAS DISCHARGED AS PLANNED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT THE ANVIL CLAMPING MECHANISM WAS DEFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557591 | TRI-STAPLE 2.0 | STAPLE, IMPLANTABLE | GDW | COVIDIEN LP LLC NORTH HAVEN | SIG60AXT | N2F0061Y | 10884521543591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |