MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-02-19 for SURGIPORT 10MM 171028 manufactured by United States Surgical Corporation.
[19]
Patient undergoing laparoscopy procedure when significant amount of bleeding was encountered on the left side of retroperitoneum. 12mm trocar placed in umbulicus. 5mm placed under direct visualization. 10mm trocar placed on left side wall. Trocar passed through mesenteric small bowel and lacerated lateral side common iliac artery/vein. Vascular surgeon called, left iliac vein repaired. Gore-tex graft to artert. Patient discharged 9 days later in stable conditiondevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 110 |
| MDR Report Key | 110 |
| Date Received | 1992-02-19 |
| Date of Report | 1992-02-04 |
| Date of Event | 1992-01-23 |
| Date Facility Aware | 1992-01-23 |
| Report Date | 1992-02-04 |
| Date Reported to FDA | 1992-02-04 |
| Date Reported to Mfgr | 1992-01-23 |
| Date Added to Maude | 1992-03-27 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGIPORT 10MM |
| Generic Name | DISPOSABLE SURGICAL TROCAR |
| Product Code | FBQ |
| Date Received | 1992-02-19 |
| Catalog Number | 171028 |
| Lot Number | P1G143 |
| Device Expiration Date | 1996-08-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 108 |
| Manufacturer | UNITED STATES SURGICAL CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-02-19 |