MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-24 for MEDIUM CLIP APPLIER 28CM PB228-1BR manufactured by Aesculap Inc.
[184250397]
Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report. Investigation on-going, if available.
Patient Sequence No: 1, Text Type: N, H10
[184250398]
It was reported that there was an issue with the clip appliers. During closure of an anterior lumbar interbody fusion (alif) surgery, the staff noticed that some of the color coding on one of the appliers was missing. This was part of the plastic-like overlay on the finger loop of the devices. There was flaking noted on all 3 devices and the surgeon's were concerned that this could have fallen inside the patient. No fragments were recovered and a decision was made not to reopen the incision. There was no known patient harm and no additional intervention. Associated medwatches: 2916714-2020-00045, 2916714-2020-00046.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00044 |
| MDR Report Key | 9746860 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY, PA |
| Manufacturer Country | US |
| Manufacturer G1 | AESCULAP INC |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIUM CLIP APPLIER 28CM |
| Generic Name | LAPAROSCOPIC SURGERY |
| Product Code | GDO |
| Date Received | 2020-02-24 |
| Model Number | PB228-1BR |
| Catalog Number | PB228-1BR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP INC |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |