MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-12-12 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..
[94567680]
(b)(4). Upon completion of the investigation it was noted that the evaluation confirmed the complaint. Sample was received and reviewed. Pattie miscount confirmed. Dhr review completed with no errors found. Tcr opened. The patties are produced in a fully automated machine with very little human intervention. Patties which have been produced are inspected using a computer vision inspection throughout the process. The final step of the process is to place the patties on the card, which is done automatically by the machine. There is a vision system which then takes a picture of the 10 strings on the card and only allows it to pass if there were 10 strings found. The automated machine used to produce this product uses a vision inspection system to 'count' the number of patties on the card. The system is very robust at finding any missing patties. Therefore, the most probable root cause lies in operator error. The operator must have dropped the rejected pattie product in the good bin. Operators are trained not to rework any product to eliminate this risk of miscounts. A tcr was opened to retrain and communicate this complaint to our operators that had worked on the lots in question. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
[94567681]
The sales rep reported that when the customer opened the package there were 9 patties instead of 10. There was no patient injury or delay in surgery as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
[112497988]
It was previously reported that the investigation found a manufacturing deficiency as the root cause. Further review of the investigation found that this could not be conclusively determined. Root cause could not be identified through evaluation of the returned device and a review of manufacturing records did not show any discrepancies. Based on the information available, root cause was not able to be determined. This report has been updated to reflect the corrected information. At present, we consider this complaint to be closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2017-10974 |
| MDR Report Key | 7110061 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-12-12 |
| Date of Event | 2017-11-22 |
| Date Mfgr Received | 2017-01-02 |
| Date Added to Maude | 2017-12-12 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL PATTIE, 1/2 X 1/2 |
| Generic Name | SURGICAL SPONGE |
| Product Code | HBN |
| Date Received | 2017-12-12 |
| Returned To Mfg | 2017-11-30 |
| Catalog Number | 80-1400 |
| Lot Number | HA6231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-12 |