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 2020-03-30 for RELIACATCH CATCH10 manufactured by Celestica Electronics S Pte Ltd.
[186019375]
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device. A visual inspection of the returned photo(s) noted that it appeared that the specimen pouch was ripped open. Due to the quality and angle of the photo it was not clear where or how the pouch was ripped. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. A definitive root cause could not be determined with regard to the reported condition. Without the physical product, a definitive root cause could not be identified. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186019376]
According to the reporter during a laparoscopic cholecystectomy, when the surgeon pulled the bag with the specimen inside, outside the incision the bag tore. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00232 |
| MDR Report Key | 9896482 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-30 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | CELESTICA ELECTRONICS S PTE LTD |
| Manufacturer Street | NO. 6 SERANGOON NORTH AVENUE 5 |
| Manufacturer City | SINGAPORE 554910 |
| Manufacturer Country | SG |
| Manufacturer Postal Code | 554910 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIACATCH |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-30 |
| Model Number | CATCH10 |
| Catalog Number | CATCH10 |
| Lot Number | C1020620A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELESTICA ELECTRONICS S PTE LTD |
| Manufacturer Address | NO. 6 SERANGOON NORTH AVENUE 5 SINGAPORE 554910 SG 554910 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |