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 2020-02-26 for C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX UNK manufactured by Applied Medical Resources.
[180901644]
No product is being returned for evaluation and no lot # has been provided to manufacturer. A follow report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[180901645]
Procedure performed: laparoscopic gastric sleeve. Rep. Wasn't present for the case. Stated that as the grasper was being rotated 90 degrees, the tip of one jaw broke off. It has been confirmed that the jaws didn't fully detach and only a piece of the jaw broke off. Nothing fell into the patient as the piece just remained "dangled" from the jaw. The surgeon was grasping omentum tissue when the breakage occurred. There were no concomitant devices and it is currently unknown as to how the case was completed. There was no patient injury and the product is not expected to return as it was discarded immediately after use. The rep. Has mentioned that this has happened a total of 3 times. Additional information was received from [name], applied medical account manager, via e-mail on february 4th, 2020: "they didn? T know the dates of the surgeries. They had to open second devices to complete the cases. The right people did not know in time to get lot # for the graspers. These were bariatric cases. The right people did not know about the device complaints until they were notified with the last case. For that matter they did not hear about the last case in order to get the grasper not a lot number. I will forward the e-mail string from the pa whom i spoke with. " intervention: opened a second device to complete the case. Patient status: no patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2020-00377 |
| MDR Report Key | 9753727 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-26 |
| 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 | C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX |
| Generic Name | LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC |
| Product Code | NWV |
| Date Received | 2020-02-26 |
| Model Number | C4130 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-02-26 |