MAUDE Adverse Event Report: CAREFUSION 2200, INC SNOWDEN-PENCER DIAMOND-LINE CLAMP DEBAKEY; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number SP90-6343

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Open or Close (2921); Output Problem (3005)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/26/2021

Event Type  malfunction  

Event Description

During the procedure, a laparoscopic grasper stopped working properly.During the case, the grasper had difficulty closing all the way.It was removed from the field and inspected by the resident.No obvious reason identified at the time.It was removed from the field and another grasper utilized.Toward the end of the procedure, under full lights, a scrub tech was able to inspect and noticed there was a missing screw but was unknown when it became missing.Patient's incisions were closed.An x-ray was taken which showed the screw in the abdomen.On discussion with family, they elected to let the patient recover rather than explore for the screw.Subsequent review indicates that it appears the screw broke.

• Brand Name: SNOWDEN-PENCER DIAMOND-LINE CLAMP DEBAKEY
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 11677639
• MDR Text Key: 245764037
• Report Number: 11677639
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SP90-6343
• Device Catalogue Number: SP90-6343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Weight: 326