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 2019-05-29 for DUCKBILL GRASP FCP ROT 5MM 35C 625118 manufactured by Integra York, Pa Inc..
[146349720]
The device was returned to the manufacturer for physical evaluation. The returned grasping forceps is a non miltex instrument. This complaint is unconfirmed; non-miltex product. Device identifier: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146349721]
A customer service associate reported in behalf of the customer that on (b)(6) 2019, the 625118 duckbill grasp fcp rot 5mm 35c was locked during a case (not specified) and it would not release causing an unspecified patient injury. It is unknown if there was any medical intervention and a surgical delay. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00072 |
| MDR Report Key | 8649465 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-04-14 |
| Date Mfgr Received | 2019-05-09 |
| Date Added to Maude | 2019-05-29 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| 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 | DUCKBILL GRASP FCP ROT 5MM 35C |
| Generic Name | GRASPING FORCEPS |
| Product Code | KNF |
| Date Received | 2019-05-29 |
| Returned To Mfg | 2019-05-14 |
| Catalog Number | 625118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-05-29 |