MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-05-29 for ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM ECS29 manufactured by Ethicon Endo-surgery, Llc.
[1158890]
It was reported by the sales rep that during a sigmoid resection procedure, the surgeon used the first device, but the staples did not form a complete b shape. The had dialed the device down to half-way in the window (1. 75mm). After the first anastomosis leaked and he started complaining the sales rep and him discussed it and that is when it was discovered that he associated the blue on our device box as 1. 5mm closed staple height on the eea. He was extremely frustrated by this and at himself, so he decided to convert to open to complete a low anterior resection with a contour device. When the surgeon opened the second device and heard the click upon connecting the anvil, the anvil kept falling off. At this point the surgeon pulled an auto suture device, but then decided to just hand sew the anastomosis closed. The patient had to have a temporary ileostomy. The ileostomy was not in the normal location. The surgeon ended up putting it at the top of the incision which he feared could cause more issues but he didn't think he had any other option at the time. The procedure started out as an hour and a half long case, but ended up six hours. The patient was released a few days later and will return in the next few weeks to determine if they can reverse the ileostomy. The pre-op diagnosis was diverticulus without hem. The surgeon said that it was your typical colon with diverticulitis and the tissue was as you would expect.
Patient Sequence No: 1, Text Type: D, B5
[8329651]
Date sent: 05/29/2009. Information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2009-03179 |
| MDR Report Key | 1396341 |
| Report Source | 07 |
| Date Received | 2009-05-29 |
| Date of Report | 2009-05-05 |
| Date of Event | 2009-05-05 |
| Date Mfgr Received | 2009-05-05 |
| Date Added to Maude | 2009-06-03 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | KATHY RICE |
| Manufacturer Street | 4545 CREEK RD |
| Manufacturer City | CINCINNATI OH 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO PR 00969 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM |
| Generic Name | KOG ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - |
| Product Code | FHM |
| Date Received | 2009-05-29 |
| Model Number | NA |
| Catalog Number | ECS29 |
| Lot Number | UNK |
| ID Number | BATCH # = NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Address | GUAYNABO PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-05-29 |