CDH #29

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-12-30 for CDH #29 manufactured by Ethicon.

Event Text Entries

[2128] 5o year old admitted for low anterior resection for ca. Ethicon cdh 29 curved intraluminal stapler was introduced via the rectum by the surgeon under direction of the sales rep. As the instrument was twisted, as directed, as directed, the cone tip perforated the posterior wall of the bowel. The instrument was removed and taken by the rep. A hand sewn anastamosis was done. Patient discharged home after a seven day length of stayinvalid 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 evaluated after the event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3555
• MDR Report Key: 3555
• Date Received: 1992-12-30
• Date of Report: 1992-12-10
• Date of Event: 1992-10-27
• Date Facility Aware: 1992-10-27
• Report Date: 1992-12-10
• Date Reported to Mfgr: 1992-10-27
• Date Added to Maude: 1993-04-23
• 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: CDH #29
• Product Code: FHM
• Date Received: 1992-12-30
• Lot Number: CL3ON
• Device Expiration Date: 1996-07-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3297
• Manufacturer: ETHICON

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-12-30