MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-06-01 for BIOPSY FORCEPS RADIAL JAW 4 STANDARD CAPACITY W/NEEDLE 2.8MM WORKING CHANNEL MIC1341 manufactured by Sterilmed, Inc..
[109801539]
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed. Since no lot number was provided, no device history record (dhr) review could be performed. Manufacturer's ref. No: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109801540]
It was reported that a patient, underwent a procedure with a biopsy forceps radial jaw 4 standard capacity w/needle 2. 8mm working channel and the patient suffered a gastrointestinal perforation. During the biopsy, the forceps tore tissue in the cecum. Two endo-clips were applied to close the tears and repair the colon. A non-recycled biopsy forceps was used to complete the biopsy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2018-00102 |
| MDR Report Key | 7561072 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-06-01 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-04-12 |
| Date Mfgr Received | 2018-05-07 |
| Date Added to Maude | 2018-06-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DR |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 763488-320 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH 55446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPSY FORCEPS RADIAL JAW 4 STANDARD CAPACITY W/NEEDLE 2.8MM WORKING CHANNEL |
| Generic Name | FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED |
| Product Code | NLU |
| Date Received | 2018-06-01 |
| Catalog Number | MIC1341 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2018-06-01 |