MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-01 for SPENCER PROBE ELECTRODES N/A SD04R-SP05X-000 manufactured by Ad-tech Medical Instrument Corp..
[147909096]
According to the customer product feedback report ((b)(4)) that alberta health services- foothills medical centre sent to surgi-one on (b)(6) 2019, this event occurred over a year ago ((b)(6) 2018). This date was confirmed with the customer. An ad-tech internal complaint investigation was performed for this issue. Specifically, a batch record review was conducted for the impacted depth electrode and no issues were noted that would contribute to the reported complaint; all manufactured electrodes passed the in-process and final quality control (qc) checks. According to customer product feedback report, the device is available for evaluation. However to date, a product return analysis has not been performed for this complaint as ad-tech is still awaiting a response from the customer to obtain the product for evaluation. Multiple attempts have been made to contact the customer. A historical complaints review was also completed for the alleged deficiency "broke off in patient". There has been one (1) similar complaint for a portion of the depth electrode breaking off in the patient's head between (b)(6) 2017 and (b)(6) 2019. There have been no capas or investigations identified within the timeframe of (b)(6) 2016 and (b)(6) 2019, related to the alleged deficiency "portion of electrode broke off in patient". A risk assessment was performed and it was found that the calculated occurrence level matches that of the risk files; thus the risk level remains at alap (as low as possible). The investigation is still on-going as ad-tech is awaiting further information from the customer.
Patient Sequence No: 1, Text Type: N, H10
[147909097]
On (b)(6) 2019 ad-tech's canadian distributor sent an email that was received from one of their customers notifying him of an issue they experienced with an ad-tech depth electrode. The report received stated the following, "patient was having four depth electrodes inserted for epilepsy monitoring. When attempting to advance one electrode, it became caught on the drilled edge of the skull and when the surgeon attempted to remove it the electrode broke off and was lodged in the patient's brain. " in a later second surgery (to remove the three remaining electrodes), the piece of the fourth electrode was also removed at that time. ". According to the distributor's customer product feedback report, there was minimum harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2019-00002 |
| MDR Report Key | 8571114 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-01 |
| Date of Report | 2019-04-01 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2019-04-01 |
| Device Manufacturer Date | 2017-07-10 |
| Date Added to Maude | 2019-05-01 |
| 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 | MRS. KATHLEEN BARLOW |
| Manufacturer Street | 400 WEST OAKVIEW PARKWAY |
| Manufacturer City | OAK CREEK 53154 |
| Manufacturer Country | US |
| Manufacturer Postal | 53154 |
| Manufacturer Phone | 2626341555 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Street | 400 WEST OAKVIEW PARKWAY |
| Manufacturer City | OAK CREEK 53154 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53154 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPENCER PROBE ELECTRODES |
| Generic Name | SPENCER PROBE ELECTRODES |
| Product Code | GZL |
| Date Received | 2019-05-01 |
| Model Number | N/A |
| Catalog Number | SD04R-SP05X-000 |
| Lot Number | 0110671 208140647 |
| Device Expiration Date | 2019-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 400 WEST OAKVIEW PARKWAY OAK CREEK 53154 US 53154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-01 |