MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-06-26 for ROTO-LOK HUNTER BOWEL GRASP 5 625164 manufactured by Integra York, Pa Inc..
[5864249]
Customer initially reports that after a procedure, a nurse found the insulation part was damaged and missing from t he tip. On (b)(6) 2015 dealer reports a laparoscopic colon resection was being performed. No pt injury or harm was reported. Insulation part wasn't found inside the pt by visual inspection or x-ray.
Patient Sequence No: 1, Text Type: D, B5
[13957963]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported info. This complaint was received in medical complaints on (b)(6) 2015.
Patient Sequence No: 1, Text Type: N, H10
[62934422]
On 07/17/2015, integra investigation completed. Method - failure analysis, device history eval results: final analysis - there was a roto-lok grasper returned in used condition showing wear, violet and grey tape/band markings, corrosion on threading and broken/cracked insulation at tip investigation. Due to the age of the instrument and not knowing how the instrument was processed/maintained, the complaint is confirmed. Dhr review was completed with all history available. Nonconforming product report / nonconforming material report history. There is no applicable nonconforming product report i nonconforming material report history. Variance authorization / deviation history. There is no applicable variance authorization / deviation history. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action, preventive action history: there is no applicable corrective action preventive action history. Health hazard evaluation history: none. Conclusion: the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00040 |
| MDR Report Key | 4875613 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-06-26 |
| Date of Report | 2015-05-01 |
| Date of Event | 2015-04-06 |
| Date Mfgr Received | 2015-06-26 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2015-07-23 |
| 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 | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTO-LOK HUNTER BOWEL GRASP 5 |
| Generic Name | GRASPING FORCEPS |
| Product Code | EIF |
| Date Received | 2015-06-26 |
| Returned To Mfg | 2015-06-30 |
| Catalog Number | 625164 |
| 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 | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-26 |