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 2020-03-23 for CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX UNK manufactured by Applied Medical Resources.
[184631166]
The event unit was not returned to applied medical for evaluation and the lot number was not provided. As the event unit was not returned, testing was unable to be performed and the complainant? S experience could not be replicated or confirmed. In the absence of the event unit, it is difficult to determine the exact root cause of the event. Applied medical has reviewed the details surrounding the event and related product. At this time, applied medical is unable to confirm that a product malfunction occurred. Applied medical will monitor its vigilance systems for any developing trends. This report represents a combined initial and follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[184631167]
Procedure performed: lap cholecystectomy. "surgeon: dr. Product: ca500 universal clip applier. Procedure: lap cholecystectomy. Contacted from account 02/26/20. Event occurred on (b)(6) 2020. I am meeting with surgeon to get event details later this afternoon. " additional information received via email on 27feb2020 from account manager "dr. Responded to my email request with the questions, but didn't answer the specific questions. " "dr had a clip not close properly and lacerate the cystic duct at the same time. " dr. Also states that there have been difficulties with the instrument not passing comfortably through a 5mm trocar. Additional information received via phone on 02mar2020 from account manager during the case dr. Placed a clip around the duct but it did not close the whole way. The surgeon removed the clip from the duct but noticed upon inspection that the duct was lacerated. Dr. Used the same clip applier to clip the duct. After the case the facility disposed of the product. The product is not available for return. Account manager has forwarded a set of follow-up questions to dr. And will attempt to retrieve pictures of the product. Additional information received via phone on 10mar2020 from account manager the rep spoke with dr. About the case. The surgeon noticed that the clip did not close properly and when removed the duct was lacerated. The doctor did not specify what intervention was necessary to treat the laceration. The trocar used was an 5mm ctf03. Patient status: no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00434 |
| MDR Report Key | 9868835 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-23 |
| 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 | CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX |
| Generic Name | CLIP, IMPLANTABLE |
| Product Code | FZP |
| Date Received | 2020-03-23 |
| Model Number | CA500 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-23 |