MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-31 for HARMONIC SCALPELS/SHEARS HAR36R manufactured by Sterilmed, Inc..
[136990636]
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 lot number provided (r94d6a) is incorrect. Follow up attempts are being made to clarify this information. A response has not yet been received. If a response is received, a 3500a supplemental report will be submitted. Since the incorrect lot number was provided, no device history record (dhr) review could be performed. Manufacturer's ref. No: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[136990637]
It was reported that a patient underwent a laparoscopic cholecystectomy procedure with harmonic scalpels/shears, and in the middle of the procedure the blade broke off the device. The surgeon retrieved the broken piece and used a new device to complete the procedure. The intent of the procedure was not altered as a result of this event. The device had patient contact, however there were no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2019-00119 |
| MDR Report Key | 8294201 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-14 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-02-18 |
| Date Added to Maude | 2019-01-31 |
| 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 | LECTROSURGICAL, CUTTING/COAGULATION ACCESSORY, LAPAROSCOPIC/ENDOSCOPIC REPROCESS |
| Product Code | NUJ |
| Date Received | 2019-01-31 |
| Catalog Number | HAR36R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-01-31 |