MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-08 for STERILMED LIGASURE 5MM MARYLAND JAW SEALER/DIVIDER COVLF1737 manufactured by Sterilmed, Inc..
[123061332]
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed. Since no lot number was provided, no device history record (dhr) review could be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123061333]
It was reported that a patient underwent a gastrectomy procedure with a sterilmed ligasure 5mm maryland jaw sealer/divider and suffered bleeding. The physician had to reopen a bariatric patient after a sleeve gastrectomy because of post-operative bleeding. The surgeon said bleeding was coming from two vessels sealed with a sterilmed ligasure maryland. The same day urgent reoperation was done to stop the bleeding. Patient was doing well after reoperation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2018-00108 |
| MDR Report Key | 7943079 |
| Date Received | 2018-10-08 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-10-15 |
| Date Added to Maude | 2018-10-08 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634883200 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STERILMED LIGASURE 5MM MARYLAND JAW SEALER/DIVIDER |
| Generic Name | ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, REPROCESSED |
| Product Code | NUJ |
| Date Received | 2018-10-08 |
| Catalog Number | COVLF1737 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-08 |