LIGACLIP ERCA ER 320

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-04 for LIGACLIP ERCA ER 320 manufactured by Ethicon Endo Surgery.

Event Text Entries

[4003] Surgeon after laparoscopic cholecystectomy had to open abdomen for uncontrolled bleeding. Vein graft repair of the hepatic artery was done. Surgeon stated that the laparoscopic clip applier may have been misfiring. Misformed staples and applier saved. 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: telemetry failure, unanticipated short term complication of procedure. Conclusion: device failure occurred and was related to event, device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: maybe. 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: 7789
• MDR Report Key: 7789
• Date Received: 1994-02-04
• Date of Report: 1993-08-03
• Date of Event: 1993-07-15
• Date Facility Aware: 1993-07-28
• Report Date: 1993-08-03
• Date Added to Maude: 1994-05-19
• 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: LIGACLIP ERCA
• Generic Name: ENOSCOPIC/ROTATING MULTIPLE CLIP APPLIER
• Product Code: FHI
• Date Received: 1994-02-04
• Model Number: ER 320
• Lot Number: EG 36 PB Y
• Device Expiration Date: 1998-01-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JUL-93
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7468
• Manufacturer: ETHICON ENDO SURGERY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-02-04