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 2019-12-30 for C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX UNKNOWN manufactured by Applied Medical Resources.
[176782742]
No product is being returned for evaluation and no lot # has been provided to manufacturer. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[176782744]
Procedure performed: colectomy. Rep wasn't informed of the complaint until today, december 11th, 2019 by the hospital coordinator, though the event occurred around a week ago exact date is unknown. Per rep, the screw at the end of the shaft that holds the jaws together jutted out and tissue was caught on the screw. The surgeon removed the caught tissue and proceeded to complete the case without any further issues. There was no patient injury and the product is not expected to return. Additional information was received, applied medical account manager associate, via e-mail on december 11th, 2019. The device did not break in any way. The screw head juts out as part of the devices new design. This same protrusion exists on every current device. Note, in the attached picture that the piece of metal connecting the jaw head to the device shaft is not flush with the shaft. This protrusion is where tissue can snag. Additional information was received, applied medical account manager associate, via e-mail on december 12th, 2019. Today i was able to meet with the doctor who is having issues with the redesigned grasper. She clarified that tissue is getting caught on the screw head and she even had bowel tissue tear during the procedure. She was able to repair the tear and the patient is fine. Intervention: removed the caught tissue from the screw and proceeded to complete the case with no further issues. Patient status: she was able to repair the tear and the patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2019-00677 |
| MDR Report Key | 9532784 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-30 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2019-12-11 |
| Date Added to Maude | 2019-12-30 |
| 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 |
| 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 | 2019-12-30 |
| Model Number | C4130 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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 | 1. Required No Informationntervention | 2019-12-30 |