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 2017-11-28 for MEMOBAG EXTRACTION BAG 200ML NA VERSION 332802-000010 manufactured by Teleflex Medical.
[93073107]
(b)(4). The device or sample has not been returned for investigation at this time. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[93073108]
Issue reported: during a laparoscopic cholecystectomy the 200ml memobag was used to retrieve the gallbladder, bag with the specimen, was pulled out through an 11-12mm defect without a ton of tension applied to remove the specimen the bag ripped before fully coming out of the defect. An applied bag was used to re-retrieve the specimen. There was no patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2017-00523 |
| MDR Report Key | 7063044 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-28 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-11-02 |
| Date Mfgr Received | 2017-12-14 |
| Device Manufacturer Date | 2016-05-04 |
| Date Added to Maude | 2017-11-28 |
| 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 | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | ARROW INTERNATIONAL CR, A.S. |
| Manufacturer Street | JAMSKA 2359/47 |
| Manufacturer City | ZDAR NAD SAZAVOU 591 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 591 01 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEMOBAG EXTRACTION BAG 200ML NA VERSION |
| Generic Name | BAG, INTESTINE |
| Product Code | KGY |
| Date Received | 2017-11-28 |
| Catalog Number | 332802-000010 |
| Lot Number | 71F16E0296 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-28 |