MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-14 for C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX 101135801 manufactured by Applied Medical Resources.
[177621326]
The event unit is anticipated to return for evaluation. A follow-up report will be provided upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[177621327]
Name of procedure being performed: na. Detailed description of event: complaint (b)(4) will address event unit 1 of 2. Complaint (b)(4) will address event unit 2 of 2. This was discovered prior to surgery and there was no patient contact. When the device was pulled from the shelf it was noted that a pinhole was on the white tyvek side of the pouch on each of the units pulled. It is unknown if the same lot was pulled for both devices. Once device was discarded by the hospital and not available for return. The other unit is available for return. The hospital has third party sourcing within the hospital and the devices are removed from the outer carton and placed on the shelf by medical staff for storage. Photographs are available. Additional information was received via email on 19dec2019 from app. Med. Acct. Mgr. : 6 photos were provided. The hospital is [name] hospital account # (b)(4). Product: alexis laparoscopic system (small). 1 each of product # c8701, # lot # 1338150. 1 each of product # c8701, # lot # 1335750. Patient status: na (before use). Type of intervention: na.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00315 |
| MDR Report Key | 9589270 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-14 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2018-10-02 |
| Date Added to Maude | 2020-01-14 |
| 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 | C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX |
| Generic Name | RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL |
| Product Code | KGW |
| Date Received | 2020-01-14 |
| Model Number | C8701 |
| Catalog Number | 101135801 |
| Lot Number | 1338150 |
| 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 | 2020-01-14 |