MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-08 for SURGICAL PATTIE, 1/2 X 1/2 80-1400 manufactured by Codman & Shurtleff, Inc..
[32976370]
Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[32976371]
Per our customer, they received a pk containing 9ea instead of 10ea of item 801400. The customer says that they do still have the pk that was missing 1ea. On 11/18/15 per distributor: did this event occur intra-operatively? Pre-operatively. Did this incident cause any delays in surgery over 30 minutes? No. Were there any adverse consequences to the patient? No. What actions were taken as a result of this incident? Complaint was filed with customer service. Cottonoids removed from room. Brought to or educator. Materials notified with item number and lot. Staff were educated.
Patient Sequence No: 1, Text Type: D, B5
[38882477]
(b)(4). Upon completion of the investigation, it was noted that 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. Automated pattie 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. Another potential location could be at the packaging step, since operators will rewrap loose strings before packaging them product. Patties can become loose when the operators are handling the cards during packaging. A tcr was opened to retrain and communicate this complaint to our operators that had worked on the lots in question. Root cause is likely due to operator error, this however could not be determined. Operators are trained to look at the patties and rewrap them if the patties become loose on the cards. A pattie could have fallen off a card and been missed by the operator. 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. Device not available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2015-10736 |
| MDR Report Key | 5275038 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-08 |
| Date Mfgr Received | 2016-01-28 |
| Date Added to Maude | 2015-12-08 |
| 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 |
| 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 | 2015-12-08 |
| Catalog Number | 80-1400 |
| Lot Number | 620847 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2015-12-08 |