MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2008-06-26 for LIGACLIP ALLPORT ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER AL326 manufactured by Ethicon Endo-surgery, Inc. (cincinnati).
[898316]
It was reported by the affiliate during an unk procedure that the device delivered malformed staples. Another like device was used. There was no pt consequence. One device returning.
Patient Sequence No: 1, Text Type: D, B5
[8078002]
Damaged kick off spring, broken feed cam. Evaluation summary: the analysis results confirmed that one al326 device was received with the kick off protruding from the jaws. When testing the device for functionality, it would not feed the clips. The instrument was disassembled to examine the condition of the internal components and the feed cam was noted to be broken therefore, the anti backup would not work making the instrument nonfunctional. We have documented the circumstances as they were reported to us. In addition, complaint info is trended on a regular basis to determine if further investigation is warranted. A batch record review was performed and no anomalies were found during the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1527736-2008-03773 |
| MDR Report Key | 1068993 |
| Report Source | 01,07 |
| Date Received | 2008-06-26 |
| Date of Report | 2008-06-03 |
| Date of Event | 2008-05-31 |
| Date Mfgr Received | 2008-06-03 |
| Device Manufacturer Date | 2007-09-04 |
| Date Added to Maude | 2009-02-20 |
| 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, INC. (INDEPENDENCIA) |
| Manufacturer Street | BLVD. INDEPENDENCIA #1151 |
| Manufacturer City | JUAREZ CHIHUAHUA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGACLIP ALLPORT ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER |
| Product Code | FHM |
| Date Received | 2008-06-26 |
| Returned To Mfg | 2008-06-18 |
| Model Number | NA |
| Catalog Number | AL326 |
| Lot Number | UNK |
| ID Number | BATCH # D9E45A |
| Device Expiration Date | 2012-08-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, INC. (CINCINNATI) |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-26 |