MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2020-01-30 for PRESTIGE ATRA GRASPERSGL-ACT5MM 36CM 8360-00 manufactured by Aesculap Inc.
[176989236]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report, if applicable or available.
Patient Sequence No: 1, Text Type: N, H10
[176989237]
It was reported that there was an issue with the prestige grasper. During a laparoscopic cholecystectomy procedure, the tip broke off into the patient. It occurred after the instrument had been put in the "open" position; upon grasping the gallbladder, it broke. An attempt was made to retrieve the tip, but it was not immediately visible. Fluoroscopy was requested, and the surgeon continued to dissect the gallbladder from the liver bed. The gallbladder was removed without incident through the trocar within an endo-catch bag. It was noted that the gallbladder had edema and some omental adhesions to fundus which was indicative of chronicity. While then visualizing under fluoroscopy, the area in the abdomen was located. Several attempts were made to find the tip of the instrument. Since the tip was deep within the tissue, and for "safety", the incision was extended. The procedure was altered and become a laparotomy in order to ensure retrieval of the piece. Additional information has been requested, but not yet received. Postoperative patient diagnosis was acute on chronic cholecystitis, and non-alcoholic fatty liver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2020-00036 |
| MDR Report Key | 9647602 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-12-10 |
| Date Added to Maude | 2020-01-30 |
| 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 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer G1 | AESCULAP INC |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18034 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESTIGE ATRA GRASPERSGL-ACT5MM 36CM |
| Generic Name | REUSABLE INSTRUMENTS |
| Product Code | NWV |
| Date Received | 2020-01-30 |
| Model Number | 8360-00 |
| Catalog Number | 8360-00 |
| Lot Number | 890715 |
| 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 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-30 |