AUTO SUTURE SURGIPORT N/A 1710-36

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-02-19 for AUTO SUTURE SURGIPORT N/A 1710-36 manufactured by United States Surgical Corporation.

Event Text Entries

[18438664] The abdominal wall at umbilical level was retracted up with towel clips. A small incision was made at the supraumbilical level. A verres needle was inserted and saline was injected to confirm free fluid flow into the abdominal cavity. The insufflattion was done with co2 and intra-abdominal pressure increased gradually to 14 mm hg. A #12 guage surgiport trocar sleeve was inserted pointing laterally. A loud popping noise was heard upon insertion which is consistant with intra-abdominial placement of the sleeve. The trocar was removed and it was noted that the protective sheath was filled with fresh blood. The lens with the video camera was suctioned and fresh blood appeared. Further inspection showed ecchymosis of the posterior peritoneum. The patient became hypotensive per anesthesia. The abdomen was imediately opened. On inspection the right iliac artery wall was lacerated anteriorly and posteriorly. The wall of the vena cava underlying the iliac artery was also lacerated. Blood flow in the aorta and vena cava was controlled with pressure on the proximal and distal portions of the vessels. The vena cava was controlled with pressure on the proximal and distal portions of the vessels. The vena cava and iliac artery were repaired. Eveenetually the common iliac artery had to be repaired with a gortex patch. Blood loss of approximately 2,000 cc was noted. Distal intravascular injection streptokinase and papaverine for thrombolysis was also done. An intraoperative arteriogram was done to confirm patency of distal vessels. The patient recuperated in icu for four days and was then transferred to pcu for further recovery. Some residual sensory impairment of the rigt foot persists at this timedevice 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. No imminent hazard to public health claimed. 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: yes. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 94
• MDR Report Key: 94
• Date Received: 1992-02-19
• Date of Report: 1992-02-06
• Date of Event: 1992-01-30
• Date Facility Aware: 1992-01-30
• Report Date: 1992-02-06
• Date Reported to FDA: 1992-02-06
• Date Reported to Mfgr: 1992-02-03
• Date Added to Maude: 1992-03-26
• 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

Device Details

• Brand Name: AUTO SUTURE SURGIPORT
• Generic Name: TROCAR & SLEEVE
• Product Code: FBQ
• Date Received: 1992-02-19
• Model Number: N/A
• Catalog Number: 1710-36
• Lot Number: P1F03
• ID Number: N/A
• Device Expiration Date: 1996-07-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JUL-91
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 92
• Manufacturer: UNITED STATES SURGICAL CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-02-19