MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-05-20 for LITHIUM ION BATTERIES - QTY 2 90522 manufactured by Integra York, Pa Inc..
[45587322]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[45587323]
Customer initially reports that this, the 2nd battery, was also getting hot inside holster on surgeons hip. On (b)(6) 2016 customer reports that doctor was performing a spinal fusion when he felt the battery was hot, after one hour of use.. Battery was removed from holster. The heat burned into the battery. No harm to the doctor. Number 2 of 2 related complaints.
Patient Sequence No: 1, Text Type: D, B5
[48205344]
On 6 /7/2016 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - battery only received. Inserted into holster, connected to led headlight, run for 2 hours on highest setting. Run time temperature 79. 8f, not an abnormal temperature for a battery in use. Battery tests within specification. Device history evaluation. Nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order / manufacturing change order history: none. Corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion: the report of battery getting hot inside holster could not be confirmed. After the evaluation of the returned sample, it was found that the battery could power a headlight and not over-heat in holster. The complaint report is unconfirmed; testing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00073 |
| MDR Report Key | 5669465 |
| Report Source | USER FACILITY |
| Date Received | 2016-05-20 |
| Date of Report | 2016-05-06 |
| Date of Event | 2016-05-04 |
| Date Mfgr Received | 2016-06-07 |
| Date Added to Maude | 2016-05-20 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITHIUM ION BATTERIES - QTY 2 |
| Generic Name | LIGHTING |
| Product Code | FSR |
| Date Received | 2016-05-20 |
| Returned To Mfg | 2016-05-19 |
| Catalog Number | 90522 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-20 |