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

Model Number	PL771SU
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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 procedure, the device sparked.The physician opened the jaws to cut the energy, however, the sealing continued for three (3) to four (4) seconds.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Based upon investigation results, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.Investigation results: visual investigation: during visual investigation no damages or defects were detected at the instrument.The mechanical check showed that the clamping and cutting function worked well.In addition a functional test was carried out and the values were within the specifications.No device problem was detected during investigation.The described error pattern cannot be confirmed.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: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.During the analysis and the functional tests, the instrument worked as expected and we could not find any malfunctions.The spark formation described in the complaint could not be verified.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: 11723418
• Report Number: 9610612-2021-00347
• Device Sequence Number: 3437290
• 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): 07/28/2021

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: 10/11/2022
• Device Model Number: PL771SU
• Device Catalogue Number: PL771SU
• Device Lot Number: 52641325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1