MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-18 for HARMONIC SCALPELS/SHEARS HAR36R manufactured by Sterilmed, Inc..
[130671497]
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. The device history record was reviewed and the records show that the device passed all visual & functional testing prior to being shipped to the account. Manufacturer's ref. No: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130671498]
It was reported that a patient underwent a lap hysterectomy procedure with a sterilmed harmonic scalpels/shears and a sealing issue occurred which caused bleeding. During the procedure, the physician complained that the product did not seal as well as other harmonic devices he has used for many years. There was more bleeding than usual; therefore, the physician had to use additional hemostatic agents to get it under control. The intent of the procedure was altered because of this event, since the physician had to use more hemostasis product as a result. Gen11 generator was used with the most current software version. The procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2018-00114 |
| MDR Report Key | 8174596 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-18 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-10-29 |
| Device Manufacturer Date | 2017-09-21 |
| Date Added to Maude | 2018-12-18 |
| 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 | HARMONIC SCALPELS/SHEARS |
| Generic Name | ELECTROSURGICAL, CUTTING/COAGULATION ACCESS, LAPAROSCOPIC & ENDO, REPROCESS |
| Product Code | NUJ |
| Date Received | 2018-12-18 |
| Returned To Mfg | 2019-02-20 |
| Catalog Number | HAR36R |
| 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 | 1. Required No Informationntervention | 2018-12-18 |