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 2020-03-26 for CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX UNK manufactured by Applied Medical Resources.
[185231304]
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 and is unable to determine the root cause of the event. 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
[185231305]
Procedure performed: laparoscopic cholecystectomy with intraoperative cholangiogram. Reps were not present for the case. Limited information is available at this time. Reps received the information 2nd hand from the materials manager. It was reported that clips failed to close on two firings on the cystic duct. The clip placed on the cystic artery scissored and severed the artery. The reps were informed that the patient status is fine. The rep will be following up with the account for additional information. It is unknown if the device is available to be returned. Additional information received via email on 12mar2020 from account mgr associate: we were able to find out a little bit more information about the incident on 3/10/2020 today while at the hospital. The original report that two clips failed to close on the cystic duct and that the 3rd clip that was fired on the cystic artery scissored and severed the artery was all accurate. The amount of bleeding can not be quantified by volume but can be described as minimal by surgeon. Below you can find more information based on your questions. The kii fios advanced fixation 5x100mm (cff03) was used with the clip applier. The artery was clamped and bleeding was minimized using laparoscopic graspers until the [name] clip was used to clip the duct and artery. The bleeding was resolved by clipping with the [name] clip applier. Not present for case but surgeon said that the tissue was larger and distal ends of clip did not fully close past the duct. The trigger was squeezed "plastic to plastic". The tip of the clip did not close. No the device is not available. Intervention: competitor device used to resolve bleeding and complete case. Patient status: fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00442 |
| MDR Report Key | 9886658 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| 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 | 2020-03-26 |