[2811]
On 3/11/92 the patient underwent a repeat c-section, with delivery of a healthy infant girl. During closure of the uterus the physician noted that the tip of suture needle was broken off. The tip was unable to be visualized or retrieved from the surgical site. An abdominal x-ray was performed in the d. R. And was negative for any retained foreign metallic body. A repeat abdominal x-ray was performed on 3/13/92 and was unremarkable. The patient was discharged in stable condition on 3/15/92. Ethicon sales rep. Was notified and made an on-site visit 3/13/92. The remaining portion of the needle is secured at the hospital and was visually inspected by the sales rep. It was not clear which lot number the needle came from as the original packaging had been discarded. Therefore, the sales rep. Removed the sutres from the two lots that were in stock in the d. R. At a future date plans will be made to conduct further studies on the remaing portion of the suture needle. Device 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 evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: invalid data. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5