MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-22 for SUBDURAL STRIP ELECTRODES UNKNOWN manufactured by Ad-tech Medical Instrument Corp..
[93295174]
As stated in the describe event section, three of the strip electrodes broke while they were being pulled out. Prior to this complaint, ad-tech had received several complaints of similar nature. Due to the number of complaints received, a corrective action/preventive action (capa) investigation was initiated to address this issue in may 2014. The probable root cause for this issue (disc dislodgement) was found to be due to percutaneous removal of the electrodes by the end user; ad-tech's directions for use (dfu) specifically states that ad-tech's subdural strip electrodes be removed surgically. As a correction to the capa, the following warning statement was incorporated into ad-tech's dfu in june 2014, "warning: percutaneous removal may result in the separation of materials, requiring surgical intervention to retrieve the electrode and contacts. " a memo was sent to all ad-tech neurosurgeon customers informing them of the addition to the dfu in june 2014. It was confirmed that this hospital acknowledged notification of this addition on 7/14/2014. On 10/9/2017, ad-tech sent the hospital an email reiterating surgically removing the electrodes and not percutaneously removing them. The dfu was also attached to the email showing the warning. An additional email was sent to the initial reporter on 10/16/2017 relaying the same information that was sent to the hospital.
Patient Sequence No: 1, Text Type: N, H10
[93295175]
On (b)(6) 2017 ad-tech received an email from a customer stating that an attempt was made to remove subdural strip electrodes from a (b)(6) male patient. Three strip electrodes broke when they were being pulled out. The patient had to be taken to the operating room to remove the segments that were retained in the head. According the customer, there was no long term harm to the patient; however, the patient had to undergo an operative procedure which would have been unnecessary had the strips not been broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2017-00011 |
| MDR Report Key | 7052655 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-10-16 |
| Date Added to Maude | 2017-11-22 |
| 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 | MRS. KATHLEEN BARLOW |
| Manufacturer Street | 1901 WILLIAM STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal | 53404 |
| Manufacturer Phone | 2626341555 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Street | 1901 WILLIAM STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBDURAL STRIP ELECTRODES |
| Generic Name | SUBDURAL STRIP ELECTRODES |
| Product Code | GYC |
| Date Received | 2017-11-22 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 1901 WILLIAM STREET RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-22 |