MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-03-15 for C8313, XXS ALEXIS WND PROT/RET 5/BX 101355501 manufactured by Applied Medical Resources.
[103090439]
Investigation summary: the event unit was not returned to applied medical for evaluation. In the absence of the subject device, it is difficult to determine the root cause of the event. 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
[103090440]
Procedure performed: revision of gastric sleeve. Event description: "dr (surgeon) inserted the xxs alexis as part of a trial of the novel approach in clinical trial for specimen removal of the gastric sleeve approach. Dr did not take off the housing of the cannula initially and alexis was difficult to insert fully and so dr pulled out the device with a toothed grasper from the housing before reinserting back into cannula without the housing. Dr inserted his fingers throughout the removal of specimen due to larger portion of stomach and toothed graspers to facilitate removal. Alexis was visible torn when surgeon removed it from the abdomen. " type of intervention: unk. Patient status: unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00087 |
| MDR Report Key | 7343906 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-15 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-02-14 |
| Date Mfgr Received | 2018-02-14 |
| Date Added to Maude | 2018-03-15 |
| 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 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 | C8313, XXS ALEXIS WND PROT/RET 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2018-03-15 |
| Model Number | C8313 |
| Catalog Number | 101355501 |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-03-15 |