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 2020-03-06 for C4130, 5MMX35CM EPIX LATIS GRASP, 10/BX 101472876 manufactured by Applied Medical Resources.
[186182185]
The incident device is anticipated to return. A follow-up report will be provided upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[186182186]
Procedure performed: lap subtotal hysterectomy and bso. Patient details: female; dob (b)(6). Dr [name] was assisting dr [name] case in a lap subtotal hysterectomy and bso; whilst using the grasper a small amount of small bowel was caught in-between the hinge of the epix grasper tips when the jaws were open and surgeon found it difficult to dislodge entrapped tissue and some bleeding occurred suggesting small injury occurred to the small bowel. Additional information was received via email from advanced procedure specialist, [name] on 14feb2020: i have spoken to [name] about this and unfortunately cannot confirm the below. Intervention: ni. Patient status: stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00410 |
| MDR Report Key | 9803203 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-08-14 |
| Date Added to Maude | 2020-03-06 |
| 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 | C4130, 5MMX35CM EPIX LATIS GRASP, 10/BX |
| Generic Name | LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC |
| Product Code | NWV |
| Date Received | 2020-03-06 |
| Model Number | C4130 |
| Catalog Number | 101472876 |
| Lot Number | 1366453 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Required No Informationntervention | 2020-03-06 |