MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-07-06 for C8323, XXS ALEXIS WND PROT/RET SHRT 5/BX manufactured by Applied Medical Resources.
[79291471]
The event device is anticipated to return. A follow-up report will be provided upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[79291472]
Procedure performed: vats. Event description: alexis tearing at (b)(6) in cardio thoracic cases. They have had 7 alexis tears in these cases. [surgeon] communicated the following regarding the device along with suggestions: -the device is tearing during insertion and removal, and not all the time. -the device placement is the same and this is occurring during vat procedures. -he is rolling the device outward as indicated. -he admitted the tearing of the plastic sheath is often caused by poking it with an object (even his own finger). One (1) device is returning on cer ((b)(4)). The other cers have no product returning ((b)(4)). Additional information received via telephone from [applied medical team member #1] on june 19, 2017 - it is unsure if the alexis model used was the c8312 or the c8322, but it is believed to be the regular xs alexis (c8312). The other products from the other cases are not available as they were disposed. Additional info received via telephone from [applied medical team member #1] and [applied medical team member #2] on june 26, 2017 - it was confirmed the product for this cer was the xx small alexis (c8323). The rest of the events have been used with the xs short alexis (c8322). It was mentioned that the tears occur during removal of the flexible ring. The surgeon explained it is difficult to get his finger around the ring to pull it out and is tearing as a result. It is tearing intraabdominally within the intercostal area above the flexible ring. According to the doctor, the reason the device is being rolled outward instead of inward because this gives the surgeon extra space when removing. Type of intervention: na. Patient status: "fine, they were not injured "
Patient Sequence No: 1, Text Type: D, B5
[129819565]
The event unit was returned to applied medical for evaluation. Upon visual inspection, engineering confirmed that there was a tear present in the film sheath. Based on the description of the event and the condition of the unit returned, it is likely that the reported event was caused by instrumentation used during the procedure. Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2017-01880 |
| MDR Report Key | 6691878 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-06 |
| Date of Report | 2017-08-30 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2017-06-15 |
| Date Added to Maude | 2017-07-06 |
| 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 | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C8323, XXS ALEXIS WND PROT/RET SHRT 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2017-07-06 |
| Returned To Mfg | 2017-07-21 |
| Model Number | 2 |
| Catalog Number | 2 |
| Lot Number | UNK |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-06 |