MAUDE Adverse Event Report: AESCULAP AG AESCULAP; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number PL740SU

Device Problems Material Fragmentation (1261); 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 was found, which looks like the protective coating of the jaws of caiman device which was chipped.Caiman was inspected and all parts accounted which was complete including the missing chipped part.

• Brand Name: AESCULAP
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): AESCULAP AG; 3773 corporate pkwy.; center valley PA 18034
• MDR Report Key: 8802193
• MDR Text Key: 151425390
• Report Number: 8802193
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• 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: 52514996
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31755 DA