MAUDE Adverse Event Report: AESCULAP AG AESCULAP CAIMAN; ELECTROSURGICAL, CUTTING & COAG

Model Number PL740SU

Device Problem Component Missing (2306)

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

Event Date 07/12/2019

Event Type  malfunction  

Event Description

Surgeon noted a piece of white plastic on the omentum, which looks like the coating / protective coating of the jaws of the caiman was inspected and all parts accounted complete with missing chip.

• Brand Name: AESCULAP CAIMAN
• Type of Device: ELECTROSURGICAL, CUTTING & COAG
• Manufacturer (Section D): AESCULAP AG; 3773 corporate pkwy.; center valley PA 18034
• MDR Report Key: 8935122
• MDR Text Key: 155659720
• Report Number: 8935122
• Device Sequence Number: 1
• Product Code: GEI
• 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: 07/23/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: PL740SU
• Device Catalogue Number: PL740SU
• Device Lot Number: 52514995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1