MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-24 for SURGIFISH 4001 manufactured by Greer Medical, Inc..
[37531455]
The directions for use states that surgifish is placed under the abdominal wall and peritoneal cavity during abdominal closure. At all times the tail portion of the surgifish must be out of the peritoneal cavity. I do not know how surgifish was used during the procedure. Surgifish is a surgical instrument and should be part of the surgical instrument count. Surgifish should be used only as described in the direction of use brochure.
Patient Sequence No: 1, Text Type: N, H10
[37531456]
On 07/18/2003 i received a letter from the (b)(4) and on (b)(6) 2003 a copy of the med watch report submitted by (b)(6). I talked to ms. (b)(6) on (b)(6) 2003. This was the first time i became aware of the incident of a retained surgifish viscera retainer. Patient is an obese patient and had a gastric stapling procedure performed. In the postoperative period, during recovery he was admitted to another hospital and the surgifish was visualized on the x-ray film during a gastrografin study. It was then removed. Surgifish contains barium sulfate and is radiopaque. The report mentioned it was not radiopaque which is not correct since it was discovered on an x-ray film at another hospital surgifish contains barium sulfate and is radiopaque as discovered at another hospital during x-rays of the abdomen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028175-2003-00001 |
| MDR Report Key | 5404451 |
| Date Received | 2003-07-24 |
| Date of Report | 2003-07-23 |
| Date of Event | 2003-06-04 |
| Date Facility Aware | 2003-07-18 |
| Report Date | 2003-07-23 |
| Date Reported to FDA | 2003-06-18 |
| Date Reported to Mfgr | 2003-07-18 |
| Date Mfgr Received | 2003-07-18 |
| Device Manufacturer Date | 2003-01-20 |
| Date Added to Maude | 2016-02-02 |
| 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 Street | 314 EAST CARRILLO ST. |
| Manufacturer City | SANTA BARBARA CA 93101 |
| Manufacturer Country | US |
| Manufacturer Postal | 93101 |
| Manufacturer Phone | 8059625883 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURGIFISH |
| Generic Name | VISCERA RETAINER TO FACILITATE ABDOMINAL CLOSURE |
| Product Code | GCZ |
| Date Received | 2003-07-24 |
| Catalog Number | 4001 |
| Lot Number | 012003 |
| Device Expiration Date | 2008-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREER MEDICAL, INC. |
| Manufacturer Address | 314 EAST CARRILLO ST. SANTA BARBARA CA 93101 US 93101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2003-07-24 |