MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-08 for HARMONIC SCALPELS/SHEARS HAR36R manufactured by Sterilmed, Inc..
[146384037]
The product has not yet been returned for analysis. Manufacturer's ref. No: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146384038]
It was reported that a (b)(6) female patient underwent a laparoscopic paraesophageal hernia repair with harmonic scalpels/shears. The greater curvature of the stomach was mobilized using the harmonic scalpel including all posterior gastric attachments beginning at the hilum of the spleen extending to the left crus of the diaphragm. The white pad tip of the harmonic scalpel hand piece started to melt and slide off. It was removed from the sterile field and replaced. All pieces were accounted for. The procedure was completed with no patient consequence. This event has been assessed as reportable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2019-00135 |
| MDR Report Key | 8592525 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-03-19 |
| Date Mfgr Received | 2019-06-04 |
| Device Manufacturer Date | 2017-10-30 |
| Date Added to Maude | 2019-05-08 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 31 TECHNOLOGY DR |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| 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 | HARMONIC SCALPELS/SHEARS |
| Generic Name | ELECTROSURGICAL,CUTTING&COAGULATION ACCESSORY, LAP & ENDOSCOPIC, REPROCESSED |
| Product Code | NUJ |
| Date Received | 2019-05-08 |
| Returned To Mfg | 2019-06-04 |
| Catalog Number | HAR36R |
| Lot Number | 1966979 |
| Device Expiration Date | 2019-10-30 |
| 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 | 2019-05-08 |