MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-03 for DYNJ901437D manufactured by Medline Industries Inc..
[88023924]
The facility reported that one of the raytec sponges became separated from the rest of the sponge and was retained in the patient. Per the facility, at the end of a laparoscopic hysterectomy procedure, a count of the sponges was performed and the count was correct. The patient was scanned per facility procedure after the patient was closed, and a sponge was detected inside the patient. The surgical staff inspected all of the sponges and noticed a sponge was missing the green chip. The surgical staff then contacted the surgeon and the patient was reopened to retrieve the green chip. There was no injury noted to the patient however the surgeon reopened the surgical site to retrieve the green chip. There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. A sample has not been returned for evaluation however, due to the reported incident and subsequent need for surgical intervention, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[88023925]
It was reported a raytec sponge was retained within the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2017-00024 |
| MDR Report Key | 6910794 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-03 |
| Date of Report | 2017-10-03 |
| Date of Event | 2017-09-06 |
| Date Mfgr Received | 2017-09-08 |
| Date Added to Maude | 2017-10-03 |
| 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 | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Manufacturer G1 | MEDLINE INDUSTRIES INC. |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SPNG LAP 18X18 XR 5/PK RFD |
| Product Code | FDE |
| Date Received | 2017-10-03 |
| Catalog Number | DYNJ901437D |
| Lot Number | 17FB5543 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-03 |