MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-07-13 for DISECT-PK CRABTREE 2 1/2MM FLT N1705 83J manufactured by Bausch + Lomb.
[79958473]
The instrument was visually inspected under a microscope. There is no evidence of material defect or manufacturing error. The instrument is bent, nicked, and broken. The instrument was manufactured prior to 2009, the instrument is stamped, laser etching was introduced in 2009. The instrument has been well used, and appears to have been abused. Cannot determine why tip broke.
Patient Sequence No: 1, Text Type: N, H10
[79958474]
The user facility reported during surgery the tip of the instrument broke off in the patient's ear. The doctor was able to remove the piece and continue with the surgery with no issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001920664-2017-00246 |
| MDR Report Key | 6710972 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-13 |
| Date of Report | 2017-06-21 |
| Date of Event | 2017-06-15 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-07-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 636226-322 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISECT-PK CRABTREE 2 1/2MM FLT |
| Generic Name | HANDHELD SURGICAL INSTRUMENT |
| Product Code | KAE |
| Date Received | 2017-07-13 |
| Returned To Mfg | 2017-06-28 |
| Model Number | N1705 83J |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Brand Name | DISECT-PK CRABTREE 2 1/2MM FLT |
| Generic Name | HANDHELD SURGICAL INSTRUMENT |
| Product Code | HNR |
| Date Received | 2017-07-13 |
| Returned To Mfg | 2017-06-28 |
| Model Number | N1705 83J |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-13 |