MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-08 for SUTURE UNKNOWN manufactured by Ethicon Inc..
[91520490]
To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. 1. Was the patient treatment altered in anyway due to the prolonged surgery time? If yes, please explain 2. Was there any patient impact (ie. Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? 3. Were there any unexpected outcomes or complications as a result of the prolonged surgery time? 4. Was the patient treatment altered in anyway due to the prolonged surgery time? If yes, please explain. 5. Was the needle removed during the first procedure? 6. What is the product code and lot number?
Patient Sequence No: 1, Text Type: N, H10
[91520511]
It was reported that the patient underwent an unknown surgical procedure on (b)(6) 2017 and the unknown suture was used. During the procedure, when holding the suture with a laparoscopic needle holder upon insertion into the trocar, the needle was detached from the strand. X-rays were taken and the needle was found inside the patient and removed. The procedure was completed as usual. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2017-71071 |
| MDR Report Key | 7011398 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-08 |
| Date of Report | 2017-10-17 |
| Date of Event | 2017-10-17 |
| Date Mfgr Received | 2017-10-17 |
| Date Added to Maude | 2017-11-08 |
| 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 | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUTURE UNKNOWN |
| Generic Name | SUTURE, NONABSORBABLE |
| Product Code | GAO |
| Date Received | 2017-11-08 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-08 |