MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-24 for BARD-PARKER? SAFESWITCH? REUSABLE SCALPEL HANDLE, SIZE 7, NON-STERILE ST-1017NS manufactured by Aspen Surgical Products, Caledonia.
[186724555]
Aspen surgical received a report from the end user indicating that during a procedure, the scalpel came off of the scalpel handle which required retrieval. No sample or photographic was provided. No adverse effect to the patient was reported. A manufacturing lot number was provided for review. As reported by the end user, during a shoulder procedure the blade came off the handle inside the patient. The blade required retrieval. The doctor had inserted the blade/handle into the shoulder to make an incision and when pulling the handle out of the body, the blade came off the handle inside the patient. Patient was not harmed. A review of the device history record showed no non-conformance's related to the reported issue. Actual device in use was not returned, however remaining units from package were tested with no blade retention issues. Based on remaining units and lot number review, cause is not establish. No further information is available on the product at this time. The device in use and photographic evidence was not available. However if any additional relevant information is identified or sample is returned, the additional relevant information will be submitted in a supplemental report. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[186724556]
Aspen surgical received a report from the end user indicating that during a procedure, the scalpel came off of the scalpel handle which required retrieval. No adverse effect to the patient was reported. The device was in use during the alleged malfunction/event. This report was filed in our complaint handling system as number c(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2020-00016 |
| MDR Report Key | 9871502 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-24 |
| 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 | MR. JORDAN HACKERT |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6165367508 |
| Manufacturer G1 | SAME AS ABOVE |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD-PARKER? SAFESWITCH? REUSABLE SCALPEL HANDLE, SIZE 7, NON-STERILE |
| Generic Name | SCALPEL HANDLE |
| Product Code | GDZ |
| Date Received | 2020-03-24 |
| Model Number | ST-1017NS |
| Lot Number | 146965 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |