ETHICON DCS12

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-22 for ETHICON DCS12 manufactured by Johnson & Johnson Company.

Event Text Entries

[4918] A surgeon was removing laparoscopic disposable 5mm scissors from 5mm bottom trocar sleeve, a slim 1" long piece of teflon coating was stripped from the scissors and dropped into abdomen. Laparotomy was then done, piece of teflon was removed, abdomen was irrigated, and systemic kefzol 1gm was administered by crna. 5mm trocar sleeve laparotomy performed and piece of teflon retrieved by surgeon. Patient admitted to hospital post surgery. Device labeled for single use. Patient medical status prior to event: invalid data. 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. Results of evaluation: telemetry failure, none or unknown, none or unknown, other. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7527
• MDR Report Key: 7527
• Date Received: 1994-02-22
• Date of Report: 1993-10-01
• Date of Event: 1993-08-24
• Date Facility Aware: 1993-08-24
• Report Date: 1993-10-01
• Date Reported to Mfgr: 1993-10-01
• Date Added to Maude: 1994-04-29
• 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: 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: ETHICON
• Generic Name: ENDOPATH DISPOSABLE CURVED SCISSOR WITH UNIPOLAR CAUTERY -5M
• Product Code: JOK
• Date Received: 1994-02-22
• Model Number: DCS12
• Catalog Number: DCS12
• Lot Number: EC8766
• Device Expiration Date: 1995-01-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JUN-93
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7206
• Manufacturer: JOHNSON & JOHNSON COMPANY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-02-22