[3603]
Two pt events. 1) during laparoscopic cholecystectomy procedure, trocar inserted and piece of plastic shield broke off and fell into pt's abdomen. No immediate post-op problems related to retained instrument noted. 2) during laparoscopic cholecstectomy procedure, portion of plastic shield trocar broke off and lodged in pt. No immediate post-op problems related to retained instrument noted. Action taken: both remaining trocars have been retained. Vendor/mfr was contacted. All same products have been removed from stock shelf in the hosp. Surgery manager requested and was sent a letter from co re: material of the safety shield and reaction of human body. Mfr verbally stated in a telephone conversation that other hosps have reported similar incidents of trocar shield's breaking. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. There was multiple patient involvement. Number of patients involved: 2. 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. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid 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