DIETHRICH BULLDOG ANG 12MM
Report
- Report Number
- 3011137372-2023-00203
- Event Type
- Malfunction
- Date Received
- August 2, 2023
- Date of Event
- July 26, 2023
- Report Date
- October 28, 2022
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- DXC
- UDI-DI
- 24026704519617
- PMA / PMN Number
- K861924
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN#: (B)(4). OTHER REMARKS: N/A. CORRECTED DATA: N/A.
(B)(4). EVALUATION OF THE RETURNED INSTRUMENT SHOWED THAT THE TIPS WERE SLIGHTLY LOOSE AND MISALIGNED IN THE CLOSED POSITION BUT THERE WAS NO VISIBLE DAMAGE TO THE JAW PIVOT PIN AREA ON THE OUTER TUBE ASSEMBLY. FUNCTIONAL TESTING REVEALED THAT THE INSTRUMENT WAS ABLE TO PICK UP, RETAIN, CLOSE, AND RELEASE MULTIPLE CLIPS WITH AND WITHOUT THE USE OF SILASTIC TEST TUBING. THE INSTRUMENT WAS DISASSEMBLED TO EVALUATE ITS INTERNAL COMPONENTS AND IT WAS FOUND THAT THE INNER DRIVE ROD BOSSES WERE BOTH DAMAGED WHERE THEY ENGAGE THE JAWS. THE DAMAGED DRIVE ROD BOSSES WERE SUSPECTED TO HAVE CAUSED THE JAWS TO BECOME SLIGHTLY LOOSE AND MISALIGNED IN THE CLOSED POSITION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE FOUND. IT COULD NOT BE CONCLUSIVELY DETERMINED WHAT CAUSED THE DRIVE ROD BOSSES TO BECOME DAMAGED BUT MISHANDLING OF THE DEVICE BY THE END USER'S FACILITY WAS SUSPECTED. NO FURTHER ACTIONS WERE REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
(B)(4). THE REPORTED COMPLAINT COULD NOT BE CONFIRMED BASED UPON EVALUATION OF THE RETURNED SAMPLE. A SAMPLE WAS RECEIVED FOR EVALUATION. NO VISUAL CONCERNS WERE NOTED. A DIMENSIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. THE DEVICE WAS FUNCTIONALLY TESTED WITH NO CONCERNS NOTED. 3 ADDITIONAL COMPLAINTS WERE RECEIVED FROM THE SAME CUSTOMER FOR THE SAME DEVICE; HOWEVER, NO CONFIRMED COMPLAINTS WERE RECEIVED IN THIS RANGE WITH THE SAME ISSUE. A TREND REVIEW WAS PERFORMED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS AND NO CONCERNS WERE NOTED. THE DEVICE FUNCTIONED AS EXPECTED AND IT WAS LIKELY THAT THE SURGEON WAS APPLYING THIS DEVICE TO A VESSEL THAT WAS BEYOND THE EFFECTIVE RANGE OF THIS CLAMP. NO FURTHER ACTIONS WERE REQUIRED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
QN#(B)(4) PENDING DEVICE INVESTIGATION OTHER REMARKS: N/A CORRECTED DATA: SECTION H10: ADDITIONAL MANUFACTURER NARRATIVE (DEVICE INVESTIGATION STILL PENDING- INCORRECT REPORT SENT IN THE PREVIOS FOLLOW-UP).
IT WAS REPORTED THAT DURING CORONARY BYPASS SURGERY, THE CLAMP IS NOT OCCLUDING THE VESSEL AS BLOOD IS STILL "GETTING THROUGH". NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
IT WAS REPORTED THAT DURING CORONARY BYPASS SURGERY, THE CLAMP IS NOT OCCLUDING THE VESSEL AS BLOOD IS STILL "GETTING THROUGH". NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
IT WAS REPORTED THAT DURING CORONARY BYPASS SURGERY, THE CLAMP IS NOT OCCLUDING THE VESSEL AS BLOOD IS STILL "GETTING THROUGH". NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
IT WAS REPORTED THAT DURING CORONARY BYPASS SURGERY, THE CLAMP IS NOT OCCLUDING THE VESSEL AS BLOOD IS STILL "GETTING THROUGH". NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695280 | DIETHRICH BULLDOG ANG 12MM | CLAMP, VASCULAR | DXC | TELEFLEX MEDICAL | UNKNOWN | 24026704519617 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |