MAUDE Adverse Event Report: AESCULAP AG CAIMAN MARYLAND ARTICULATING D5/360MM; BIPOLAR TECHNOLOGIES

Model Number	PL771SU
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Intra-Abdominal Hemorrhage (4479)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that a caiman maryland articulating d5/360mm (part # pl771su) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the surgery, the patient vessel bleed.The complaint device was returned to the manufacturer for evaluation.Patient was reported as doing well.No need for open surgery.Although requested, additional information has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation results/ visual investigation: first we made a visible inspection of the jaw.Except minor soiling (blood and tissue,we found no abnormalities like burned or charred peak.Then we checked the mechanical function.The clamping and the cutting function worked well.In the next step we connected the instrument with an rf- generator "gn 200", snr.1510, and checked the electrical functions.In the next step we checked the function and the resistance of the system.Therefore we cleaned the jaw with hydrogen peroxide.Then we connected the instrument to the module box and measured the voltage drop over the instrument.With the voltage drop and the known current, it is possible to calculate the real resistance on load operation.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: in the complaint description it is mentioned, that an error message appeared on the generator display.The ifu points out, that in cases of error messages and in doubt of insufficient sealing the sealing an additional sealing cycle is necessary.If the error message appears again, the instrument must be changed and the sealing with dubious must not be cut.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), and *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.Based upon the investigations results a capa is not necessary.

• Brand Name: CAIMAN MARYLAND ARTICULATING D5/360MM
• Common Device Name: BIPOLAR TECHNOLOGIES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12820619
• Report Number: 9610612-2021-00711
• Device Sequence Number: 4905664
• Product Code: GEI
• UDI-Device Identifier: 04046964837333
• UDI-Public: 4046964837333
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2021
• Device Model Number: PL771SU
• Device Catalogue Number: PL771SU
• Device Lot Number: 52522829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male