MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-03 for TC IRIS SCISSORS CVD S/S 110MM BC211R manufactured by Aesculap Ag.
[140876544]
(b)(4). No product at hand. Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown. Conclusion and root cause: no product available, therefore a conclusion and root cause cannot be conclusively defined. Based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage. Rationale: based on the quality standards and the device history record we exclude a material or manufacturer caused error. Without the product, we cannot determine the exact cause. If further investigations are required, the product should be provided for examination. No capa is necessary. If additional information is received a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[140876545]
It was reported the tip broke intra-operatively. During a nasal surgical procedure the tip of the iris scissors broke while being used in the patient's nose. The surgeon found and retrieved the small piece with difficulty. An x-ray was performed to confirm that there were no remaining parts inside the nose. No other intervention or delay reported. No patient information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00193 |
| MDR Report Key | 8480579 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-03 |
| Date of Event | 2019-03-06 |
| Date Facility Aware | 2019-03-14 |
| Date Mfgr Received | 2019-03-11 |
| Date Added to Maude | 2019-04-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TC IRIS SCISSORS CVD S/S 110MM |
| Generic Name | BASIC INSTRUMENTS |
| Product Code | LRW |
| Date Received | 2019-04-03 |
| Model Number | BC211R |
| Catalog Number | BC211R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-03 |