MAUDE Adverse Event Report: CAREFUSION 2200, INC SNOWDEN-PENCER; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number SP90-3003

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2019

Event Type  No Answer Provided  

Event Description

Laparoscopic re-usable instrument broke while in abdomen.Jaws let go.

Event Description

Laparoscopic re-usable instrument broke while in abdomen.Jaws let go.

• Brand Name: SNOWDEN-PENCER
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 9284177
• MDR Text Key: 165271654
• Report Number: 9284177
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SP90-3003
• Device Catalogue Number: SP90-3003
• Device Lot Number: -
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1