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

Model Number	PL771SU
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
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 that there was an issue with pl771su - caiman maryland articulating d5/360mm.According to the complaint description, during the operation two products did not seal sufficiently.The failure occur before application.There was no described patient harm.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information - block d9 investigation results: leading device reference code pl771su device name caiman maryland articulating d5/360mm serial number n/a batch number 52637101 2x manufacturing date (b)(6) 2020 the instruments arrived in a contaminated condition.Failure description the instruments exhibit no outwardly damages or defects.Used test- and analysis- equipment: aesculap rf- generator "gn 200", snr.1510 digital-camera "panasonic dmc tz8" fluke 178 trms multimeter (id 1838) measuring module box with power supply first we made a visible inspection of the jaw of both instruments.Here we found no abnormities like burned or charred peak.Then we checked the mechanical function.The clamping and the cutting function of both instruments worked well.In the next step we connected the instruments with an rf- generator "gn 200", snr.1510, and checked the electrical functions: test step: generator- announcement: result: instrument "a" activation with open jaw "regrasp open" o.K.Activation with wet tissue "sealing" o.K.Activation with closed jaw "regrasp open" o.K.Activation with tin-foil in jaw "regrasp short" o.K.Instrument "b" activation with open jaw "regrasp open" o.K.Activation with wet tissue "sealing" o.K.Activation with closed jaw "regrasp open" o.K.Activation with tin-foil in jaw "regrasp short" o.K.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 well known current, it is possible to calculate the real resistance on load operation.Result: resistance on load operation instrument "a" at 1 a: 2,0 resistance on load operation instrument "b" at 1 a: 1,8 the upper limit of the resistance of the complete instrument is 4,0 and the determined value therefore in specification on both instruments.Next with a clearance gauge we checked the clearance between the upper and the under jaw in closed position.The values of both instruments are within specification.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.Explanation and rationale 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) choice of the wrong parameter (standard / plus- mode) conclusion and root cause due to the current deviation and according to the explanation and rationale, the root cause of the problem is most probably patient-related and usage-related.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
• MDR Report Key: 11446463
• Report Number: 9610612-2021-00155
• Device Sequence Number: 19796655
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 09/21/2022
• Device Model Number: PL771SU
• Device Catalogue Number: PL771SU
• Device Lot Number: 52637101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1