MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-28 for BIOPSY PUNCH FCPS 5X6X3MM 210MM ER068R manufactured by Aesculap Ag.
[131713175]
(b)(4). Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[131713176]
It was reported that during collection of a sample, the biopsy punch stopped biting. This resulted in a short delay of the procedure; however, no patient harm occurred. The report indicates this is the second issue with this device this year, date of occurrence of first occurrence is unknown at the time of this report. All medwatch reports associated with these reported incidents include: 9610612-2018-00606 (this report) 2nd occurrence, 9610612-2018-00607.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00606 |
| MDR Report Key | 8203319 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-28 |
| Date of Report | 2019-01-24 |
| Date of Event | 2018-12-05 |
| Date Facility Aware | 2019-01-10 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2018-05-01 |
| Date Added to Maude | 2018-12-28 |
| 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 | BIOPSY PUNCH FCPS 5X6X3MM 210MM |
| Generic Name | BIOPSY PUNCH |
| Product Code | HFB |
| Date Received | 2018-12-28 |
| Returned To Mfg | 2018-12-20 |
| Model Number | ER068R |
| Catalog Number | ER068R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-12-28 |