VISISTAT 35R 6/BOX
Report
- Report Number
- 3003898360-2022-00310
- Event Type
- Malfunction
- Date Received
- July 25, 2022
- Date of Event
- July 7, 2022
- Report Date
- July 7, 2022
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- QQS
- UDI-DI
- 14026704631770
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS WAS CONDUCTED AS FOLLOWS: P/N 528135 IS NOT BEING MANUFACTURED CURRENTLY, HOWEVER, ANOTHER PART NUMBER FROM THE SAME FAMILY WAS USE FOR THE "VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS" AND WAS CONDUCTED AS FOLLOWS: (B)(4) STAPLERS WERE TAKEN FROM THE CURRENT PRODUCTION FROM P/N 528435 DEROYAL SURGIMATE 35W 24/ CASE LOT# 73G2200158 THE STAPLERS WERE FUNCTIONALLY INSPECTED AND ISSUE REPORTED "MISFIRE/JAMMING - STAPLES NOT FIRING" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS, THE STAPLES WERE LOADED AND RELEASED CORRECTLY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. ACCORDING TO UPS, THE SAMPLE WAS DELIVERED TO THE MORRISVILLE FACILITY. HOWEVER, THERE IS NO EVIDENCE THAT THE SAMPLE WAS RECEIVED. A NONCONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THE MISSING SAMPLE. SINCE THE SAMPLE CANNOT BE FOUND, THE COMPLAINT CANNOT BE CONFIRMED. IF THE SAMPLE IS FOUND AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.
(B)(4). PER DHR THE PRODUCT VISISTAT 35R 6/BOX LOT # 73B2200012 WAS MANUFACTURED ON 02/01/2022 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON 02/14/2022. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. P/N 528135 IS NOT BEING MANUFACTURED CURRENTLY, HOWEVER, ANOTHER PART NUMBER FROM THE SAME FAMILY WAS USE FOR THE "VERIFICATION OF FAILURE MODE REPORTED IN THE CURRENT MANUFACTURING PROCESS" AND WAS CONDUCTED AS FOLLOWS: 13 STAPLERS WERE TAKEN FROM THE CURRENT PRODUCTION FROM P/N 528435 DEROYAL SURGIMATE 35W 24/ CASE LOT# 73G2200158 THE STAPLERS WERE FUNCTIONALLY INSPECTED AND ISSUE REPORTED "MISFIRE/JAMMING - STAPLES NOT FIRING" WAS NOT OBSERVED IN THE CURRENT MANUFACTURING PROCESS, THE STAPLES WERE LOADED AND RELEASED CORRECTLY. REVISION OF FMEA-08-028 REV 05 WAS PERFORMED AND THE FAILURE MODE IS ALREADY INCLUDING IT, NO UPDATE IS REQUIRED. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE ALLEGED DEFECT. AT THIS TIME DUE THE SAMPLE IS NOT AVAILABLE IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE PRODUCT SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINATE THE ROOT CAUSE.
STAPLES ARE NOT RELEASING WHEN HANDLE IS SQUEEZED, OR THEY ARE FALLING OUT AND DO NOT BEND TO FORM THE STAPLED SHAPE.
STAPLES ARE NOT RELEASING WHEN HANDLE IS SQUEEZED, OR THEY ARE FALLING OUT AND DO NOT BEND TO FORM THE STAPLED SHAPE.
STAPLES ARE NOT RELEASING WHEN HANDLE IS SQUEEZED, OR THEY ARE FALLING OUT AND DO NOT BEND TO FORM THE STAPLED SHAPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572533 | VISISTAT 35R 6/BOX | STAPLE, REMOVABLE (SKIN) | QQS | TELEFLEX MEDICAL | IPN028492 | 73B2200012 | 14026704631770 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |