MAUDE Adverse Event Report: AESCULAP AG CAIMAN MARYLAND ARTICULATING D5/360MM; SEAL & CUT INSTRUMENTS

Model Number	PL771SU
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap ag that a caiman 5, maryland articulating vessel sealer (part # pl771su) was used during a procedure on an unknown date.According to the complainant, the physician claimed that the device failed to seal suffciently, and that the bleed continued.This malfunction prolonged the surgery for less than 15 minutes.Additional information was requested, but has not been made available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.Because the caiman system is validated, and the complained instrument is without any deviation to the function relevant parameters we assume a usage and / or patient related error.Possible root causes for insufficient sealing are: insufficient cleaning of the electrodes (usage).Blood clotting disorder (patient).Cutting before the end of sealing cycle signal (usage).All instruments were tested on their electrical and physical properties.A material failure or a manufacturing error can be excluded.After the 8d report no capa is necessary.

• Brand Name: CAIMAN MARYLAND ARTICULATING D5/360MM
• Common Device Name: SEAL & CUT INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10938743
• Report Number: 9610612-2020-00862
• Device Sequence Number: 11836019
• Product Code: GEI
• UDI-Device Identifier: 04046964837333
• UDI-Public: 4046964837333
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K183180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 01/16/2022
• Device Model Number: PL771SU
• Device Catalogue Number: PL771SU
• Device Lot Number: 52577602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1