MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-27 for TISHLER MORGAN BIOPSY PUNCH 64-689 manufactured by Coopersurgical, Inc..
[57863833]
Coopersurgical inc. Is currently investigating the reported complaint condition. The device involved in the complaint has not been returned by the customer for evaluation. Once the investigation is completed a follow-up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[57863834]
"punches dull/doctor unable to get good sample. " "patient had significant pain and bleeding trying to get a biopsy. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[58370781]
On 07/15/2015 coopersurgical inc. Is currently investigating the reported complaint condition. The device involved in the complaint has not been returned by the customer for evaluation. Once the investigation is completed a follow-up report will be filed. (b)(4). On 10/22/2015 investigation summary report: review dhr: inspect returned samples. The returned sample was a warranty repair item. The returned instrument was reviewed by a service and repair technician and found the punch needed to be sharpened (see repair order (b)(4)). This part is purchased from a supplier and is packaged at coopersurgical. This particular instrument was packaged in nov. 2014 and sent to the customer in dec. 2014. A review of the dhr (b)(4) did not find any abnormalities. A review of two year complaint history found two similar complaints. The punch is a known wear item from use and requires sharpening.
Patient Sequence No: 1, Text Type: N, H10
[58370782]
"punches dull/doctor unable to get good sample. " "patient had significant pain and bleeding trying to get a biopsy. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2015-00056 |
| MDR Report Key | 5612461 |
| Date Received | 2016-04-27 |
| Date of Report | 2015-08-10 |
| Date of Event | 2015-07-15 |
| Date Mfgr Received | 2015-07-21 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2016-04-27 |
| 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 | MR. NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TISHLER MORGAN BIOPSY PUNCH |
| Generic Name | TISHLER MORGAN BIOPSY PUNCH |
| Product Code | HFB |
| Date Received | 2016-04-27 |
| Returned To Mfg | 2015-07-15 |
| Model Number | 64-689 |
| Catalog Number | 64-689 |
| Lot Number | 4175 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-27 |