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 2018-01-03 for C8313, XXS ALEXIS WND PROT/RET 5/BX 101355501 manufactured by Applied Medical.
[96395562]
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
[96395563]
Procedure performed: excision biopsy cervical node incident description: first time meeting [physician] who is an ent surgeon. Agreed to try an alexis for his excision biopsy of cervical node. In serviced on how to use before the procedure and showed him and his registrar a video of the alexis being used in a thyroidectomy. After making his incision and skin flap he tried to place the xs akexis but it was too large. I opened a sterile xxs which fit in the skin flap. When rolling the alexis down [physician] and [his registrar] held the outer ring either side and rolled downwards. The sheath became twisted as they rolled down so they were unable to get the circumfriental retraction. They tried to correct the twist but it didn't work so they removed the alexis by bulling the string through the middle. When the alexis was passed to the scrub nurse i noticed it had torn where the sheath was twisted over the outer ring. Mentioned to the surgeon about the rip and he was aware of the rip and thinks he may have caused it when rolling the sheath down. Patient status: did a patient injury or illness occur associated with the complaint event? No. Type of intervention: ni.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00001 |
| MDR Report Key | 7162466 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-03 |
| Date of Report | 2018-03-19 |
| Date of Event | 2017-12-18 |
| Date Mfgr Received | 2017-12-18 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2018-01-03 |
| 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 | C8313, XXS ALEXIS WND PROT/RET 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2018-01-03 |
| Returned To Mfg | 2018-02-02 |
| Model Number | C8313 |
| Catalog Number | 101355501 |
| Lot Number | 1270927 |
| Device Expiration Date | 2019-05-13 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-03 |