ENDOPATH LKR73

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-13 for ENDOPATH LKR73 manufactured by Ethicon.

Event Text Entries

[3056] Patient scheduled for laparoscopic cholecystectomy. Case began at 1252 hours on 6/16/93. Patient was insufflated. Surgeon attempted to insert trocar three times. On third time plastic tip of sheath broke off. Surgeon attempted larparoscopic retreival of broken piece, but was unsuccessful. Patient had to be opened to retreived piece and finish operation. No other devices in use at same time of incident. Invalid data - regarding single use labeling of device. 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: device permanently removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5668
• MDR Report Key: 5668
• Date Received: 1993-07-13
• Date of Report: 1993-06-21
• Date of Event: 1993-06-16
• Date Facility Aware: 1993-06-16
• Report Date: 1993-06-21
• Date Reported to Mfgr: 1993-06-16
• Date Added to Maude: 1993-07-20
• 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: ENDOPATH
• Generic Name: RADIOLUCENT 100MM -10/11 MM DIAMTER
• Product Code: FBQ
• Date Received: 1993-07-13
• Model Number: LKR73
• Catalog Number: LKR73
• Lot Number: DEA2922
• Device Expiration Date: 1998-01-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5367
• Manufacturer: ETHICON

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-07-13