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 2019-01-17 for 5MM MARYLAND JAW SEALER/DIVIDER, 37CM COVLF1737 manufactured by Sterilmed, Inc..
[133521207]
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. As such, the investigation will be closed. If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate. The device history record (dhr) was reviewed and no discrepancies observed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[133521208]
It was reported that a patient underwent a laparoscopically assisted vaginal hysterectomy procedure with a 5mm maryland jaw sealer/divider, 37cm and the surgeon advised the ligasure worked the first time properly, then felt that it was sticking and not cauterizing. The device did contact the patient and the tips were sticking to healthy tissue. There was no end tone or error tone from the device. Another refurbished maryland ligasure was used to complete the procedure and there was no patient consequence. The intent of the procedure was not altered as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2019-00118 |
| MDR Report Key | 8259381 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-07 |
| Date of Event | 2019-01-07 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2018-05-09 |
| Date Added to Maude | 2019-01-17 |
| 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 | 9497898687 |
| 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 | 3 |
| Brand Name | 5MM MARYLAND JAW SEALER/DIVIDER, 37CM |
| Generic Name | ELECTROSURG, CUTTING/COAGULATION ACCESS, LAPAROSCOP/ENDOSCOP, REPROCESSED |
| Product Code | NUJ |
| Date Received | 2019-01-17 |
| Returned To Mfg | 2019-01-21 |
| Catalog Number | COVLF1737 |
| Lot Number | 2010707 |
| Device Expiration Date | 2019-05-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-17 |