MAUDE Adverse Event Report: AESCULAP AG CAIMAN EINM.INSTR.N.ABWINKELB.D5/360MM; ADVANCED ENERGY

Model Number	PL740SU
Medical Device Problem Code	Energy Spectrum Incorrect (1210)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aeculap ag that a caiman einm.Instr.N.Abwinkelb.D5/360mm (part # pl740su) was used during a procedure performed on an unknown date.According to the complainant, the caiman used in the procedure sometimes failed to coagulate or only partially coagulated, despite the machine warning that the synthesis cycle had been completed.In particular, when the user of the product contacted, he described three situations within the surgery where the product caused bleeding.The first, more serious one, the machine warned that the synthesis/coagulation cycle had been carried out on the tissue in the bite, but in reality there was no current delivery, this misled the doctor who cut the tissue with the appropriate cutting function, which generated a bleed that required suturing.The other two were minor bleeds because there was a partial current delivered by the unit.The complaint device was returned to the manufacturer for evaluation.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: the instrument arrived in a contaminated condition, because decontamination would cover important traces and make error analysis impossible.Except for the soiling, we found no abnormalities like burned or charred peak.Then we checked the mechanical function.The clamping and 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: 2 of the 4 functions did not pass.In the next step we checked the function and 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.In the next step we opened the handle to investigate the sliding contacts.Here we found the distal sliding contact contaminated with dried blood.The review of risk assessment revealed that the overall risk level (3(5) severity x 2(5) probability of occurrence) according to din en iso 14971 is still acceptable.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale: proper sliding contacts have a resistance of nearly 0 ohm.The resistance of each slider contact and the resistance of the tissue between the jaw- electrodes build a series circuit.In an electrical series circuit, all resistances add up to form a total resistance.During the sealing process the rf generator measures the resistance of the whole circuit.Here it is assumed that the electrical resistance of the sliding contacts is zero and the only resistance is the resistance of the tissue to be sealed.During the sealing process the resistance of the tissue between the jaw- electrodes increases (the electrical resistance increases due to the evaporation of the tissue fluid) and above a certain resistance value, the generator reports "sealing finished".If there is an impermissible resistance at the sliding contacts, this is included in the overall measurement and falsifies the result with the effect that the generator ends the sealing too early.This is in this case the root causes for insufficient sealing.Furthermore an additional resistance on the sliding contact (s) reduces the sealing performance.The most probable root cause for the soiling in the present case is a damaged sealing in the shaft end, most likely caused by a manufacturing (assembling) error.Conclusion and root cause: due to the current deviation, and according to explanation above, the root cause of the problem is most probably manufacturing-related.Corrective action: a capa is not necessary.

• Brand Name: CAIMAN EINM.INSTR.N.ABWINKELB.D5/360MM
• Common Device Name: ADVANCED ENERGY
• 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: 13112113
• Report Number: 9610612-2021-00785
• Device Sequence Number: 3536963
• Product Code: GEI
• UDI-Device Identifier: 04046964693953
• UDI-Public: 4046964693953
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151696
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 05/26/2023
• Device Model Number: PL740SU
• Device Catalogue Number: PL740SU
• Device Lot Number: 52688508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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: Required Intervention
• Patient Sex: Unknown