MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-06-05 for STEVENS TENOTOMY SCISSORS CVD 4.5IN OP5693 manufactured by Carefusion, Inc.
[110085520]
(b)(4) on 21may2018 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event. Writer provided contact information. Device not yet evaluated, if the device is evaluated a follow up will be sent.
Patient Sequence No: 1, Text Type: N, H10
[110085521]
Via phone conversation: the instrument shattered at the joint in the middle of surgery. On 23may2018 additional information: 1. Did any part the instrument fall into the patient? S body, and if so how was it retrieved? They did not believe, other than the point that broke off fell into the incision, but they did irrigate and debride, just in case. 2. Was there a medical procedure performed to verify if the instrument was in the patient? S body, such as an x-ray? They did not do an x-ray, only visual examination. 3. What was the patient? S outcome? Patient's outcome, so far, has been good. No infection or complications. 4. Was the procedure completed as planned? Procedure completed as planned. 5. Can you please send all parts of the instrument for evaluation? All parts that were received in decontamination were sent. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2018-00010 |
| MDR Report Key | 7569279 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-06-05 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-05-18 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2018-06-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEVENS TENOTOMY SCISSORS CVD 4.5IN |
| Generic Name | SCISSORS, OPHTHALMIC |
| Product Code | LRW |
| Date Received | 2018-06-05 |
| Returned To Mfg | 2018-05-29 |
| Catalog Number | OP5693 |
| Lot Number | XRDX10 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061 |
| Brand Name | STEVENS TENOTOMY SCISSORS CVD 4.5IN |
| Generic Name | SCISSORS, OPHTHALMIC |
| Product Code | HNF |
| Date Received | 2018-06-05 |
| Returned To Mfg | 2018-05-29 |
| Catalog Number | OP5693 |
| Lot Number | XRDX10 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-05 |