MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-27 for PRO-STAY 8/PK 3205-8G manufactured by Coopersurgical, Inc..
[44581739]
Coopersurgical inc. Is currently investigating the reported complaint condition. The device involved in the complaint has not yet been returned by the customer for evaluation. A follow-up report will be filed with investigation findings. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44581740]
"twice during operations the plastic hook of the elastic stays broke and the little parts fell into the wound thus causing additional procedures to remove them from the body. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[47762363]
Reference e-complaint number (b)(4). Investigation: x-initiated manufacturer's investigation, no sample returned, x-review dhr, x-inspect returned samples, inspect stock product. Analysis and findings: dhr review of wo#147552 shows pn 3205-8g was made in may 2013 and was manufactured, assembled, inspected and tested per established procedures and there were no issues identified in the device(s). These pro-stay 8pk stays are meant for gentle retraction and is labeled with pn 828-3290 that states "notice: do not use forceps. Use gentle retraction". 71 finished units were manufactured in this lot. Review of part history shows from 1999 the pn 828-3290 label has been in use. Review of component parts shows: pn 720-3205 molded hook from lot 126133 of total quantity (b)(4) were molded in 2012 and have been used in 14 other pn 3205-8g lots. There was one other complaint from lot in sep 2014 where the "stay tip separated from the stay tail". That investigation confirmed that more than 8. 8lbf force was used to pull apart the stay head from the tail. No tips were broken in that case. In 2011 a similar complaint for broken hook cc#776 was investigated which confirmed an excessive force of 18. 5 lbf or more caused the tip to break. Closer investigation of returned parts was performed under magnification. The surfaces where the tips broke appear uneven and are not clean cuts, confirming application of excess force during retraction. Root cause: an excessive amount of force applied caused the molded stay tips to break. Correction and/or corrective action: formal track and trend per established lonestar procedures. Corrective action level: none. Reason: warning label is included in the product.
Patient Sequence No: 1, Text Type: N, H10
[47762364]
"twice during operations the plastic hook of the elastic stays broke and the little parts fell into the wound thus causing additional procedures to remove them from the body. " ref e-complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2016-00002 |
| MDR Report Key | 5613341 |
| Date Received | 2016-04-27 |
| Date of Report | 2016-02-02 |
| Date of Event | 2016-01-07 |
| Date Mfgr Received | 2016-01-07 |
| Device Manufacturer Date | 2013-07-02 |
| 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 | PRO-STAY 8/PK |
| Generic Name | ELASTIC STAYS PRO-STAY 8/PK |
| Product Code | GDG |
| Date Received | 2016-04-27 |
| Model Number | 3205-8G |
| Catalog Number | 3205-8G |
| Lot Number | 147562 |
| Device Expiration Date | 2018-05-29 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 |