MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-22 for PROVOX INSERTION SYSTEM 22.5FR 8019 manufactured by Atos Medical Ab.
[70789370]
Investigation: folding tool and insertion tube were intact. The insertion pin was broken in two parts. Approximately 10 mm of the pin head was broken from the rest of the pin. The safety strap of the voice prosthesis was still attached to the rest of the pin. The areas around the fracture were investigated; the remained shaft of the pin head shows imprints from a toothed hemostat. The two imprints seams to correlate to each other as coming from one grip with a toothed hemostat; a theory is that this occurred when removing the interrupted part from the prosthesis. There are also deformations on the edges of the slot in the pin head. It is difficult to say how such deformations have occurred during the natural handling. However, it might have occurred when handling the interrupted part with a tool after the removal. Internal investigation: we have tried to provoke fracture at insertion pins by rough handling during insertion of prostheses in an artificial fistula without success. It is however possible to break the insertion pin if subjecting the material to a substantial and very fast bending movement. Conclusion/action: the cause of the break is likely that the insertion pin was exposed to an unusually high and rapid bending force during the insertion that resulted in abnormal stress to the product.
Patient Sequence No: 1, Text Type: N, H10
[70789371]
We have received a complaint from (b)(6) in the (b)(6) regarding a broken inserter pin at insertion. Representative from atos medical (b)(4) had a face to face meeting with the surgeon and the surgeon went through how he had used the system and explained the chain of events as: loading the vega 22. 5fr 6mm voice prostheses onto the insertion pin of the provox insertion system. Assembling the pin and the folding tool. Observation: the surgeon did not pull the pin into its locked position and started to pinch the tool with part of the valve outside the folding tool. He explained that he did not really recall how he did the preloading but that he did preload the vega and aligning the valve with the visual ring of the loading tube. As the distance between the te puncture and the posterior esophageal wall, in the patient, was quite short, he explained that he tried to wiggle the tip of the loading tube into a good position in the puncture. The vega was deployed and was accidently overshot. The inserter pin was removed in a rapid sideways movement. Using two hemostats, the tracheal flange of the vega was grasped with one hemostat and the other was used to slowly rotating the valve back into the puncture stepwise, re-gripping with the hemostat between each step. When approximately 50 % of the tracheal flange was visible it was noted that part of the insertion pin was also in the puncture (unclear if it was still attached to the vega or if it was detached). The lose/broken end of the insertion pin was grasped using the hemostat and removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2017-00003 |
| MDR Report Key | 6423650 |
| Date Received | 2017-03-22 |
| Date of Report | 2017-03-03 |
| Date of Event | 2017-03-03 |
| Date Mfgr Received | 2017-03-03 |
| Device Manufacturer Date | 2017-01-24 |
| Date Added to Maude | 2017-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KAROLINA NILSSON |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-24222 |
| Manufacturer Phone | 641519800 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-24222 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROVOX INSERTION SYSTEM 22.5FR |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2017-03-22 |
| Returned To Mfg | 2017-03-09 |
| Catalog Number | 8019 |
| Lot Number | 1701179 |
| Device Expiration Date | 2017-12-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | KRAFTGATAN 8 HORBY, SE-24222 SW SE-24222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-22 |