MAUDE Adverse Event Report: AESCULAP INC. CAIMAN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PL720SU
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2014
Type of Reportable Event	Malfunction
Event or Problem Description
Device stopped cauterizing during laparoscopic colectomy.Delay in surgery as a result: 2 minute delay.Generator functioned as intended.Instrument stopped sealing after six to ten successful seals.Device was being used to seal omentum.Tissue was sealed with full jaw.Vessel was clamped perpendicular (90°).Instrument had not required cleaning.No notable blood loss.Surgery was completed with another caiman device.
Additional Manufacturer Narrative
This report is being submitted retrospectively per fda request.The adverse event is filed under aic reference (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

• Brand Name: CAIMAN
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 6524719
• Report Number: 2916714-2014-00975
• Device Sequence Number: 18682594
• Product Code: GEI
• UDI-Device Identifier: 04046964093784
• UDI-Public: (01)04046964093784(11)140630(17)160531(10)52046686
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: PL720SU
• Device Catalogue Number: PL720SU
• Device Lot Number: 52046686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2014
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2014
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 04/26/2017
• Date Device Manufactured: 06/30/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown