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 2017-09-22 for 3M SURGICAL CLIPPER PROFESSIONAL 9681 N/A manufactured by 3m Health Care.
[87175958]
S/n unknown and will attempt to get it. No udi applies in gudid for this is a class i device which is not currently under udi requirements. There is no expiration date on this product only the blades that are used with the clipper. The defect occurred on the clipper handle. The investigation is still pending. There was an injury to a patient which was reported under 2110898-2017-00124. There was one clipper used but resulted in two incidents during use.
Patient Sequence No: 1, Text Type: N, H10
[87175959]
A male hospital technician was using the surgical clipper on the abdomen of a male patient prior to bariatric surgery. After 8-10 minutes of clipping, the technician alleged a small shock-like sensation from the clipper. The technician alleged black "fumes" came from the clipper. He alleged the fumes temporarily "blinded" him. The technician set the clipper on the patient during which a blast was alleged from the clipper. Smoke allegedly came from the clipper; the room smoke detector sounded. The clipper fell from the patient to the floor. The technician was seen in the emergency room for observation. Medical treatment was not specified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00125 |
| MDR Report Key | 6888655 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-22 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-08-24 |
| Date Mfgr Received | 2017-08-24 |
| Device Manufacturer Date | 2015-11-12 |
| Date Added to Maude | 2017-09-22 |
| 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 | MS. LINDA JOHNSEN |
| Manufacturer Street | 2510 CONWAY AVE. 3M CENTER, BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | 3M HEALTH CARE INFECTION PREVENTION DIVISION |
| Manufacturer Street | 2510 CONWAY AVE 3M CENTER |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M SURGICAL CLIPPER PROFESSIONAL |
| Generic Name | SURGICAL CLIPPER |
| Product Code | LWK |
| Date Received | 2017-09-22 |
| Model Number | 9681 |
| Catalog Number | N/A |
| Lot Number | 20151102 |
| Operator | HOSPITAL SERVICE TECHNICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-22 |