MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-28 for NITINOL COMPRESSION ANASTOMOTIC DEVICE manufactured by Unknown.
[3414419]
On (b)(6) 2013, the pt had a laparoscopic low anterior resection for a diverticular stricture at the rectosigmoid junction. Pt did well and was sent home on post-op day 3. On (b)(6) 2013, pt was having a bowel movement and experienced sudden onset of severe pain. Was taken to the emergency room where physical exam and labs were consistent with possible sepsis. Pt taken to the operating room, abdomen opened where a significant amount of purulence and feculence was washed out. Entire bowel run with no problems found until site of the colorectal anastomosis was reached. The compression ring that was used to perform the anastomosis was present at the rectal junction open to the abdomen and was easily removed without any force. Anastomotic disruption suspicious for failure of the compression stapling device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029559 |
| MDR Report Key | 3032525 |
| Date Received | 2013-03-28 |
| Date of Report | 2013-03-28 |
| Date of Event | 2013-02-25 |
| Date Added to Maude | 2013-04-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NITINOL COMPRESSION ANASTOMOTIC DEVICE |
| Generic Name | UNKNOWN |
| Product Code | LNN |
| Date Received | 2013-03-28 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | UNKNOWN UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-03-28 |