MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-29 for HIGH FLOW INSUFFLATION TUBING WITH FILTER 20400162S manufactured by Karl Storz Endoscopy-america, Inc..
[53333194]
Patient Sequence No: 1, Text Type: N, H10
[53333195]
The physician was performing a laparoscopic oophorectomy. At the start of the procedure she hooked up the veress needle to a storz high flow insufflation tubing (with filter) cat # 20400162s, lot # 117891. The insufflator tubing is used to regulate the now rate and pressure of co2 used to distend the abdomen during laparoscopy. However, the tubing did not work as it should. The pressure in the abdomen was not regulated. The belly was noted to be distended at approximately the same time that the patient's vital signs were also reacting and the patient was becoming bradycardic. The physician immediately disconnected the tubing and deflated the abdomen and the patient's vital signs returned to normal. A new tubing was connected and worked as it was supposed to.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5909868 |
| MDR Report Key | 5909868 |
| Date Received | 2016-08-29 |
| Date of Report | 2016-08-19 |
| Date of Event | 2016-08-10 |
| Report Date | 2016-08-19 |
| Date Reported to FDA | 2016-08-19 |
| Date Reported to Mfgr | 2016-08-19 |
| Date Added to Maude | 2016-08-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH FLOW INSUFFLATION TUBING WITH FILTER |
| Generic Name | TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC |
| Product Code | NKC |
| Date Received | 2016-08-29 |
| Catalog Number | 20400162S |
| Lot Number | 117891 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 2151 EAST GRAND AVE. EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-29 |