MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-06-02 for OMNIGRAFT AND DISPOSABLE STAPLER KIT 4CM X 4CM DFU4041S manufactured by Integra Lifesciences Corporation.
[77422907]
Integra has completed their internal investigation on may 27, 2017: results: the failure is unconfirmed as there was no product returned for this complaint. Failure analysis could not be performed. Dhr review; no anomalies found. Complaints history; a query was performed using the keywords? Stapler? And? Staple? For complaints issued within from 20-mar-2016 through 20-mar-2017; one additional complaint was found related to the omnigraft stapler malfunction. Another query was performed searching for complaints related to lot # 105ka0352098 or stapler lot 16ob7589; no additional complaints were found. There have been (b)(4) omnigraft devices sold in the past 12 months. As per the trending queries, there have been (b)(4) complaints identified for stapler malfunction. Therefore, the calculated complaint rate is (b)(4). Conclusion: the root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10
[77422908]
It was reported that as the customer was placing the omnigraft into the wound and securing it with the provided stapler, the stapler failed to fire anymore staples after 3. The doctor kept squeezing the trigger and even tried to pull out the next staple thinking that it was jammed. Before giving up, the sales rep asked the doctor if he could look at the stapler to see if he could fix it. He put on sterile gloves and began messing with the stapler. He quickly noticed that the trigger handle was stuck, meaning that it was not returning to its original position. This action was not allowed the following staple to advance forward so that the staple could then be pushed down into the skin. He had to manually pull the trigger down so that the staple could advance. Once he did this, the doctor could continue using the staple gun for 4 more staples without an issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2017-00008 |
| MDR Report Key | 6609414 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-06-02 |
| Date of Report | 2017-03-20 |
| Date Mfgr Received | 2017-05-27 |
| Date Added to Maude | 2017-06-02 |
| 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 |
| Reporter Occupation | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIGRAFT AND DISPOSABLE STAPLER KIT 4CM X 4CM |
| Generic Name | INTEGRA OMNIGRAFT DERMAL REGENERATION MATRIX |
| Product Code | MDD |
| Date Received | 2017-06-02 |
| Catalog Number | DFU4041S |
| Lot Number | 1745570 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-02 |