MAUDE Adverse Event Report: AESCULAP AG CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM; BIPOLAR TECHNOLOGIES

Model Number	PL720SU
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
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 that there was an issue with pl720su - caiman disp.Instr.Non articul.D:5/360mm.According to the complainant, during the procedure, the device took time to seal the vessels.Reportedly, there was no hemostasis.The complaint device has not been 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
Investigation results/ visual investigation: the instrument exhibits no outwardly damages or defects.First we made a visible inspection of the jaw.Here we found no abnormities 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 opened the handle to investigate the sliding contacts.Here we found the distal sliding contact (conduction to the shaft and the lower jaw) heavy soiled.This blood soiling is the reason for a too high resistance of the junction between the rf- power source (rf- generator) and the jaw.The measured resistance, the specification is lower than 2 ohm.The root cause for the problem is a blood contamination of the distal sliding contact in the instrument.These blood-caused contamination arise when blood rises through the instrument shaft up into the handle, caused by overpressure in the situs.Usually a seal implemented in the shaft prevents blood leaking into the handle.In the event of high gas pressures in the situs or due to excess temperature (impermissible reprocessing) or manufacturing errors (defective seal).In rare cases, blood can penetrate the handle and thus contaminate the sliding contacts and the associated increase in the contact resistance.The exact cause cannot be finally concluded.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 the risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 2(5)) 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 clear indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM
• Common Device Name: BIPOLAR TECHNOLOGIES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11924908
• Report Number: 9610612-2021-00432
• Device Sequence Number: 923763
• Product Code: GEI
• UDI-Device Identifier: 04046964013744
• UDI-Public: 4046964013744
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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: 10/06/2021
• Device Model Number: PL720SU
• Device Catalogue Number: PL720SU
• Device Lot Number: 52558825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1