MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2010-07-22 for IS PAC INTER SORB PLUS C02 ABSORBENT CANISTER 2216 manufactured by Intersurgical, Inc..
[1368625]
During a product trial two of the canisters appeared to develop a leak 60 to 90 minutes into the surgical procedure. The two canisters passed the initial pressure test. Six additional cannisters failed the initial pressure test. Two add'l canisters were found to be cracked when removed from their shipping case and not tested for use. All ten cannisters were discarded. When the first canister leaked during use, the surgical procedure was stopped and the patient was bagged until the canister was replaced. No intervention was required when the second canister leaked was a replacement canister was on hand in the operating room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319447-2010-00001 |
| MDR Report Key | 1775742 |
| Report Source | 01,05,06 |
| Date Received | 2010-07-22 |
| Date of Report | 2010-07-23 |
| Date of Event | 2010-07-13 |
| Date Mfgr Received | 2010-07-19 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2011-03-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN ROBINSON, VP |
| Manufacturer Street | 417 ELECTRONICS PKWY. |
| Manufacturer City | LIVERPOOL NY 13088 |
| Manufacturer Country | US |
| Manufacturer Postal | 13088 |
| Manufacturer Phone | 3154512900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IS PAC INTER SORB PLUS C02 ABSORBENT CANISTER |
| Generic Name | ABSORBENT CANISTER |
| Product Code | CBL |
| Date Received | 2010-07-22 |
| Model Number | 2216 |
| Lot Number | 1101511 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSURGICAL, INC. |
| Manufacturer Address | 417 ELECTRONICS PKWY. LIVERPOOL NY 13088 US 13088 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-07-22 |