MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-28 for IPC? HANDPIECE - XPS? STRAIGHTSHOT? M4 1898200TRF manufactured by Medtronic Xomed Inc..
[185494488]
Analysis found that the customer complaint of overheating could not be confirmed since the device was not tested for pre-temperature test. However, it was found that the handpiece was stalling but was working. All the internal parts were corroded. There was foreign material built-up on rear bearings and the cable was cut. Removed the foreign material and replaced with new rear seals and bearing and motor cable assembly. Also replaced old serial number (b)(4) with new udi serial (b)(4). The device was repaired, cleaned, tested and passed all manufacturing specifications. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185494489]
A health care provider (hcp) reported that the handpiece was not working properly. There was no patient impact. On follow-up, it was reported that the handpiece was running hot during set-up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00189 |
| MDR Report Key | 9893137 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2013-07-23 |
| Date Added to Maude | 2020-03-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IPC? HANDPIECE - XPS? STRAIGHTSHOT? M4 |
| Generic Name | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE |
| Product Code | ERL |
| Date Received | 2020-03-28 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 1898200TRF |
| Catalog Number | 1898200TRF |
| Lot Number | 207217376 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-28 |